As of January 31, 2023, Sponsors are required to submit all new trial applications for authorization in the European Union through the Clinical Trial Information System (CTIS) in compliance with the new European Union Clinical Trials Regulation (EU CTR). With the new regulation, Sponsors are seeking guidance with questions such as: what types of documents to include, processes, timelines, and how to protect confidential information, among others. Not fully understanding the process could result in releasing unprotected data or withdrawing the application due to unmet deadlines and requirements.
https://info.mmsholdings.com/eu-ctr-compliance-success-updates-submissions-for-eu-ctis-portal
The new Clinical Trial Regulation (No. 536/2014) will come into effect in 2018 and replace the current Directive 2001/20/EC. The Regulation aims to streamline the clinical trial application process and increase transparency. Key changes include a single EU portal for electronic submission, a coordinated review process with defined timelines, and increased public access to trial information. There will be a three year transition period for ongoing trials to transition to the new system. Ivowen is available to support companies with regulatory submissions and compliance under the new Regulation.
This document summarizes the key aspects of the new European Union Clinical Trial Regulation 536/2014. It introduces the new regulation and highlights major differences from the previous Clinical Trial Directive 2001/20, including streamlining the authorization process, establishing a single application and decision per member state, and increased transparency requirements. An overview is provided of the new centralized submission and authorization process using the European Portal and Database. Processes for modifications, safety reporting, and inspections are also summarized.
EU Clinical Regulation Webinar Slide Deck.pptxMMS Holdings
The webinar discusses key changes introduced by the new EU Clinical Trials Regulation that will revolutionize clinical trial transparency in Europe. Some of the major changes include a single application portal, expanded data disclosure requirements, and public access to clinical study documents and results. The new regulation aims to streamline the application process and increase oversight and transparency of clinical trials conducted in the European Union.
Review of essential documents (TMF BABE).Piyush Wagh
This ppt is useful for the Clinical Auditors (BABE), it helps in reviewing of essential documents and compilation of essential documents during clinical phase. Bioequivalence
Clinical Research Regulation in European Union ShantanuThakre3
The document discusses clinical research regulations in the European Union. It provides information on the aim of the European Medicines Agency (EMA) in regulating clinical trials to protect subjects' rights and safety. It describes the EMA's role in ensuring good clinical practice standards across the European Economic Area. It also summarizes key points of the new Clinical Trials Regulation, including requirements for authorization, informed consent, and conducting trials on vulnerable groups. Finally, it discusses the Clinical Trials Information System that will support application and oversight of trials under the new Regulation.
The document summarizes changes to ISO 14155:2020 for clinical investigations involving medical devices. It notes that the standard now explicitly includes post-market investigations and software devices. Key changes include expanded risk-based monitoring allowing on-site or centralized approaches, new event escalation procedures, and emphasis on risk management throughout the clinical trial process. While GCP principles are becoming more aligned between ISO 14155 and ICH-GCP, some differences remain in adverse event reporting and how product risks and training are addressed.
This document outlines quality system requirements for national pharmaceutical inspection services that conduct GMP inspections of manufacturers and wholesale distributors. It specifies that inspection services must establish a quality manual, administrative structure, documentation control, records management, inspection procedures and resources, internal audits, quality improvement processes, and procedures for handling complaints and recalls. The goal is to achieve consistency in inspection standards across national authorities to facilitate mutual recognition and confidence between inspection services.
Easy! Have a look at our diagram on how the submission process looks like. It is never been easier - with Cunesoft you are prepared for upcoming submission mandates. Check our eCTD submission software cune-eCTD here: https://cunesoft.com/en/products/ectd/
The new Clinical Trial Regulation (No. 536/2014) will come into effect in 2018 and replace the current Directive 2001/20/EC. The Regulation aims to streamline the clinical trial application process and increase transparency. Key changes include a single EU portal for electronic submission, a coordinated review process with defined timelines, and increased public access to trial information. There will be a three year transition period for ongoing trials to transition to the new system. Ivowen is available to support companies with regulatory submissions and compliance under the new Regulation.
This document summarizes the key aspects of the new European Union Clinical Trial Regulation 536/2014. It introduces the new regulation and highlights major differences from the previous Clinical Trial Directive 2001/20, including streamlining the authorization process, establishing a single application and decision per member state, and increased transparency requirements. An overview is provided of the new centralized submission and authorization process using the European Portal and Database. Processes for modifications, safety reporting, and inspections are also summarized.
EU Clinical Regulation Webinar Slide Deck.pptxMMS Holdings
The webinar discusses key changes introduced by the new EU Clinical Trials Regulation that will revolutionize clinical trial transparency in Europe. Some of the major changes include a single application portal, expanded data disclosure requirements, and public access to clinical study documents and results. The new regulation aims to streamline the application process and increase oversight and transparency of clinical trials conducted in the European Union.
Review of essential documents (TMF BABE).Piyush Wagh
This ppt is useful for the Clinical Auditors (BABE), it helps in reviewing of essential documents and compilation of essential documents during clinical phase. Bioequivalence
Clinical Research Regulation in European Union ShantanuThakre3
The document discusses clinical research regulations in the European Union. It provides information on the aim of the European Medicines Agency (EMA) in regulating clinical trials to protect subjects' rights and safety. It describes the EMA's role in ensuring good clinical practice standards across the European Economic Area. It also summarizes key points of the new Clinical Trials Regulation, including requirements for authorization, informed consent, and conducting trials on vulnerable groups. Finally, it discusses the Clinical Trials Information System that will support application and oversight of trials under the new Regulation.
The document summarizes changes to ISO 14155:2020 for clinical investigations involving medical devices. It notes that the standard now explicitly includes post-market investigations and software devices. Key changes include expanded risk-based monitoring allowing on-site or centralized approaches, new event escalation procedures, and emphasis on risk management throughout the clinical trial process. While GCP principles are becoming more aligned between ISO 14155 and ICH-GCP, some differences remain in adverse event reporting and how product risks and training are addressed.
This document outlines quality system requirements for national pharmaceutical inspection services that conduct GMP inspections of manufacturers and wholesale distributors. It specifies that inspection services must establish a quality manual, administrative structure, documentation control, records management, inspection procedures and resources, internal audits, quality improvement processes, and procedures for handling complaints and recalls. The goal is to achieve consistency in inspection standards across national authorities to facilitate mutual recognition and confidence between inspection services.
Easy! Have a look at our diagram on how the submission process looks like. It is never been easier - with Cunesoft you are prepared for upcoming submission mandates. Check our eCTD submission software cune-eCTD here: https://cunesoft.com/en/products/ectd/
Marketing authorization procedures in euRajaniKarpur
There are three main procedures for obtaining marketing authorization in the EU:
1. Centralized Procedure allows applicants to obtain approval in all EU countries by applying to the EMEA and results in a binding Commission decision. It is mandatory for certain product types.
2. Mutual Recognition Procedure involves approval in multiple countries based on recognition of an existing national authorization. Applications are made to both a Reference and Concerned Member States.
3. Decentralized Procedure is similar but applies to products without prior EU authorization. Applications are made simultaneously to a Reference and Concerned Member States.
The document discusses clinical trial regulation in the European Union. It provides information on two key directives - Directive 2001/20/EC which describes requirements for conducting clinical trials in the EU, and Commission Directive 2005/28/EC which implements principles of good clinical practice. It then summarizes Regulation 536/2014 adopted in 2014 which established a new regulation for clinical trials of medicinal products in the EU with the aim of increasing patient safety, reliability of data, and efficiency of trials. The regulation includes provisions for single submission of documentation, centralized assessment, transparency, informed consent, and safety reporting among others.
Regulatory dossier preparation and submission as per CTD formatAvinash sharma
This document provides an overview of regulatory dossier preparation and submission using the Common Technical Document (CTD) format. It defines a regulatory dossier and describes the two main types: ICH-CTD and ASEAN CTD. It lists several countries and their respective regulatory authorities. The CTD is explained as a joint format maintained by regulatory agencies in Europe, Japan, and the US. The five CTD modules are outlined which contain administrative, quality, non-clinical, and clinical information. Finally, it compares paper, NeeS, and eCTD submission formats in terms of features like type, compilation, and submission method.
Presented by Antoinette Azevedo, e-SubmissionsSolutions.com at Documentation and Training Life Sciences, June 23-26, 2008 in Indianapolis.
Life sciences regulatory authorities in North America, Europe and Japan have been developing standards for drug and biologic registration submissions in electronic format for over ten years. The current version of the format—electronic Common Technical Document (eCTD)—has been the recommended format since 2005 and is on the way to becoming mandatory. This presentation will provide an overview of best practices to enable a sponsor to prepare a compliant eCTD for regulatory authority review.
A California biotech submitted an eCTD to the US FDA in summer 2005. This company used commercial-off-the-shelf publishing software, experienced consultants, and in-house staff to compile this eCTD. This drug was the biotechs first candidate for commercialization. The biotech was partnered with big Pharma to assist with sales and marketing after the FDA authorized the drug for marketing. The biotech hired a sales force of nearly 200 in anticipation of FDA approval.
The FDA issued a refuse-to-file on this eCTD in fall 2005, due to problems with the PDF files and navigability of the content of the submission. The company’s market capitalization dropped 50% overnight. The company had to recompile the submission, by reworking the source files and rebuilding the XML backbone. The new version of the eCTD was resubmitted in early 2006. The FDA accepted the resubmission for review.
However, in May 2006 the FDA issued an approvable letter, that meant the drug could be approved in the future if certain conditions were met (meaning yet another delay in being able to market the product, plus additional expense to conduct further clinical studies). In June, 2006, the big pharma company terminated the partnership with the biotech. In July 2006, the biotech laid off their sales force. In August, 2006, the biotech laid off 100 more employees. In September 2006, the biotech had a meeting with FDA to discuss what additional studies and analysis was needed. Finally, in January 2007, the biotech announced plans to resubmit its NDA by end of second quarter 2007.
This presentation will describe:
* Regulatory and business drivers behind the eCTD format
* Technical components of an eCTD
* Practical implications of collecting documents and data over the discovery, development, application review, and post-marketing lifecycle phases of a drug or biological product
* Global picture for adoption of the eCTD format
* Future direction for the eCTD format
* Role of electronic document management in the eCTD lifecycle
* Top 12 Issues FDA Has with eCTD and how to avoid them
* Preparing submission-ready source documents and data for submission in eCTD
* Whether to purchase an eCTD publishing system or to outsource.
* How to prepare for the technical challenges of eCTD
Electronic submissions allow companies to submit regulatory applications like NDAs, BLAs, and INDs to agencies electronically instead of via paper. The eCTD format is now the preferred standard, organized into folders with an XML backbone and PDF files. Key benefits of electronic submissions include faster review times, elimination of duplicate documents, improved records management and archiving. While challenges remain, the future is a fully electronic environment across all FDA divisions to increase efficiency.
The European Medicines Agency (EMA) regulates medicines for human and veterinary use in Europe. Based in London, the EMA ensures medicines are safe and effective, working with authorities in EU member states. Over its 25 year history, the EMA has authorized over 1000 human and 200 veterinary medicines. While facilitating timely access to medicines, the EMA monitors safety and provides information to healthcare professionals and patients, but does not regulate pricing, advertising, patents, or certain other products. The EMA comprises several scientific committees and is supported by the European Directorate for Quality of Medicines.
The document discusses the basics of clinical research and clinical trials. It covers the key steps in drug discovery and development including target selection, validation, drug selection, optimization, pre-clinical and clinical testing. Clinical trials are systematic investigations in human subjects to evaluate safety and efficacy of new drugs, and are done in 4 phases. It takes approximately 10-12 years and $800 million to bring a new drug to market. Regulations, stakeholders, essential documents, and infrastructure requirements for clinical trials are also outlined.
Post Marketing Requirements/Complaince: PMRs and PMCsDr. Reena Malik
This document discusses post-marketing requirements (PMRs) and post-marketing commitments (PMCs) required of drug sponsors after FDA approval. PMRs are studies required by regulation, while PMCs are studies agreed upon between the sponsor and FDA but not required. Sponsors must periodically report on the status of PMRs and PMCs, with certain details like enrollment required for clinical trials. The FDA provides guidance and websites for sponsors to report and check the status of post-marketing studies.
Regulatory requirnment and approval procedure of drugs in japan pptsandeep bansal
this ppt is about all the rules and regulations of drugs in Japan.this ppt contains the PMDA structure, DMF data, IND and NDA procedure, cosmetic regulations, post marketing survelliance etc.
Marketing Authorization Procedure in European UnionDoninder Hooda
The document discusses marketing authorization procedures in the European Union. It provides an overview of the general principles of marketing authorization and describes the key procedures including the national procedure, centralized procedure, mutual recognition procedure, and decentralized procedure. It outlines the mandatory and optional scopes of the various procedures and summarizes the timelines, responsibilities, and advantages and disadvantages of each authorization route.
The document discusses the electronic common technical document (eCTD) format for regulatory submissions to agencies like the FDA. It describes the structure of an eCTD, which includes five modules containing administrative information, summaries, quality details, nonclinical studies, and clinical studies. It also discusses the process of developing and submitting an eCTD, including using XML and PDF files. Regulatory agencies in countries like the US, EU, Japan and Canada accept eCTD submissions for applications like new drug applications.
7 Steps - How to Get a CE Marking Certification for Medical Devices?Puneet sharma
The document outlines the 7 steps to obtain CE marking certification for a medical device: 1) Classify the device, 2) Identify relevant standards and regulations, 3) Compile technical documentation and testing results, 4) Appoint a European authorized representative if located outside the EU, 5) Obtain certification from a notified body for class II/III devices or self-certify for class I, 6) Affix the CE marking, and 7) Comply with any national requirements. The service described can assist manufacturers with all aspects of the certification process.
Regulatory documents are required by health authorities before approval of new drugs, devices, or biologics. These documents include protocols, clinical study reports, investigator brochures, common technical documents, informed consent forms, and risk management plans. Protocols describe the study procedures and analysis plans. Clinical study reports integrate full study reports according to ICH guidelines. Investigator brochures provide safety information to investigators. Common technical documents assemble quality, safety, and efficacy data for regulatory submissions. Informed consent forms provide study information for participants. Risk management plans describe safety profiles and risk minimization plans.
clinical trial Management with ethics committeeSrinivasanBB
The document discusses key aspects of clinical trial management including experimental units, treatment and evaluation, approaches to clinical trials, the roles of various organizations, and essential documents. It provides definitions for experimental units and outlines how treatments and evaluations are conducted in clinical trials. It describes the trial approach process including principal investigators, feasibility questionnaires, ethics committee approval, and registration. It also outlines the roles of site management organizations, ethics committees in reviewing protocols and risks/benefits, and regulatory requirements in India including the Drug and Cosmetic Act, regulatory bodies, and the application process. Finally, it discusses important documents for conducting and reporting clinical trials.
The document discusses the European Drug Master File (EDMF), which was established in 1989-1991 and later revised in 2005. The EDMF, also known as an Active Substance Master File (ASMF), contains confidential manufacturing information that is divided into an applicant's part and a restricted part. The applicant's part is provided to marketing authorization applicants, while both parts are submitted to health authorities. The EDMF system aims to protect proprietary information while providing sufficient data to support drug approvals and ensure product quality.
This document discusses investigational device exemption (IDE) and post marketing surveillance. IDE allows investigational devices to be used in clinical studies to collect safety and effectiveness data, requiring approval by an institutional review board and FDA for significant risk devices. Post marketing surveillance monitors the safety of medical devices after market release using approaches like spontaneous reporting databases and patient registries to identify potential safety issues and provide long-term monitoring of effects. Both are important parts of ensuring device safety during development and after approval.
This document summarizes the objectives and classification system of the Global Harmonization Task Force (GHTF) for in vitro diagnostic (IVD) medical devices. The GHTF was founded in 1993 to harmonize medical device regulations globally. It aims to facilitate trade while preserving public health. IVD medical devices are classified into 4 risk-based classes (A to D) based on 16 general rules related to device invasiveness, energy use, and disease detection. Class A devices pose the lowest risk while Class D the highest. The classification system aims to ensure regulatory oversight is proportionate to device risk.
Clinical evaluation is the process of assessing clinical data to verify the safety and performance of a medical device for its intended use. It involves three main stages: 1) identifying existing clinical data from literature and reports, 2) appraising individual data sets for sufficiency, and 3) analyzing the overall strength of evidence and conclusions about safety and performance. If existing data is insufficient, new clinical evaluations must be conducted. A clinical evaluation report is prepared when existing data demonstrates conformity with essential requirements.
Planning and management of a clinical trial abroad Zeta Research
An Italian medical device manufacturer wanted to conduct a post-market clinical trial abroad to obtain marketing data quickly. A contract research organization proposed conducting the randomized controlled trial at an investigational site in an extra-EU country to maximize resources and expedite the 6-7 month timeline for analyzed data. The CRO planned to translate and adapt the study documents to local requirements, monitor the site, obtain ethics approval, manage products on site, and analyze data remotely according to good clinical practice to meet the client's goals in a cost-effective manner.
Developing strategies for contract adherence in medical devices cro contractsErik Vollebregt
This presentation was delivered at the Outsourcing in Clinical Trials: Medical Devices Europe 2016 conference in München on 17 February 2016. It covers do's and don'ts for CRO contracts in the medical devices sector.
Marketing authorization procedures in euRajaniKarpur
There are three main procedures for obtaining marketing authorization in the EU:
1. Centralized Procedure allows applicants to obtain approval in all EU countries by applying to the EMEA and results in a binding Commission decision. It is mandatory for certain product types.
2. Mutual Recognition Procedure involves approval in multiple countries based on recognition of an existing national authorization. Applications are made to both a Reference and Concerned Member States.
3. Decentralized Procedure is similar but applies to products without prior EU authorization. Applications are made simultaneously to a Reference and Concerned Member States.
The document discusses clinical trial regulation in the European Union. It provides information on two key directives - Directive 2001/20/EC which describes requirements for conducting clinical trials in the EU, and Commission Directive 2005/28/EC which implements principles of good clinical practice. It then summarizes Regulation 536/2014 adopted in 2014 which established a new regulation for clinical trials of medicinal products in the EU with the aim of increasing patient safety, reliability of data, and efficiency of trials. The regulation includes provisions for single submission of documentation, centralized assessment, transparency, informed consent, and safety reporting among others.
Regulatory dossier preparation and submission as per CTD formatAvinash sharma
This document provides an overview of regulatory dossier preparation and submission using the Common Technical Document (CTD) format. It defines a regulatory dossier and describes the two main types: ICH-CTD and ASEAN CTD. It lists several countries and their respective regulatory authorities. The CTD is explained as a joint format maintained by regulatory agencies in Europe, Japan, and the US. The five CTD modules are outlined which contain administrative, quality, non-clinical, and clinical information. Finally, it compares paper, NeeS, and eCTD submission formats in terms of features like type, compilation, and submission method.
Presented by Antoinette Azevedo, e-SubmissionsSolutions.com at Documentation and Training Life Sciences, June 23-26, 2008 in Indianapolis.
Life sciences regulatory authorities in North America, Europe and Japan have been developing standards for drug and biologic registration submissions in electronic format for over ten years. The current version of the format—electronic Common Technical Document (eCTD)—has been the recommended format since 2005 and is on the way to becoming mandatory. This presentation will provide an overview of best practices to enable a sponsor to prepare a compliant eCTD for regulatory authority review.
A California biotech submitted an eCTD to the US FDA in summer 2005. This company used commercial-off-the-shelf publishing software, experienced consultants, and in-house staff to compile this eCTD. This drug was the biotechs first candidate for commercialization. The biotech was partnered with big Pharma to assist with sales and marketing after the FDA authorized the drug for marketing. The biotech hired a sales force of nearly 200 in anticipation of FDA approval.
The FDA issued a refuse-to-file on this eCTD in fall 2005, due to problems with the PDF files and navigability of the content of the submission. The company’s market capitalization dropped 50% overnight. The company had to recompile the submission, by reworking the source files and rebuilding the XML backbone. The new version of the eCTD was resubmitted in early 2006. The FDA accepted the resubmission for review.
However, in May 2006 the FDA issued an approvable letter, that meant the drug could be approved in the future if certain conditions were met (meaning yet another delay in being able to market the product, plus additional expense to conduct further clinical studies). In June, 2006, the big pharma company terminated the partnership with the biotech. In July 2006, the biotech laid off their sales force. In August, 2006, the biotech laid off 100 more employees. In September 2006, the biotech had a meeting with FDA to discuss what additional studies and analysis was needed. Finally, in January 2007, the biotech announced plans to resubmit its NDA by end of second quarter 2007.
This presentation will describe:
* Regulatory and business drivers behind the eCTD format
* Technical components of an eCTD
* Practical implications of collecting documents and data over the discovery, development, application review, and post-marketing lifecycle phases of a drug or biological product
* Global picture for adoption of the eCTD format
* Future direction for the eCTD format
* Role of electronic document management in the eCTD lifecycle
* Top 12 Issues FDA Has with eCTD and how to avoid them
* Preparing submission-ready source documents and data for submission in eCTD
* Whether to purchase an eCTD publishing system or to outsource.
* How to prepare for the technical challenges of eCTD
Electronic submissions allow companies to submit regulatory applications like NDAs, BLAs, and INDs to agencies electronically instead of via paper. The eCTD format is now the preferred standard, organized into folders with an XML backbone and PDF files. Key benefits of electronic submissions include faster review times, elimination of duplicate documents, improved records management and archiving. While challenges remain, the future is a fully electronic environment across all FDA divisions to increase efficiency.
The European Medicines Agency (EMA) regulates medicines for human and veterinary use in Europe. Based in London, the EMA ensures medicines are safe and effective, working with authorities in EU member states. Over its 25 year history, the EMA has authorized over 1000 human and 200 veterinary medicines. While facilitating timely access to medicines, the EMA monitors safety and provides information to healthcare professionals and patients, but does not regulate pricing, advertising, patents, or certain other products. The EMA comprises several scientific committees and is supported by the European Directorate for Quality of Medicines.
The document discusses the basics of clinical research and clinical trials. It covers the key steps in drug discovery and development including target selection, validation, drug selection, optimization, pre-clinical and clinical testing. Clinical trials are systematic investigations in human subjects to evaluate safety and efficacy of new drugs, and are done in 4 phases. It takes approximately 10-12 years and $800 million to bring a new drug to market. Regulations, stakeholders, essential documents, and infrastructure requirements for clinical trials are also outlined.
Post Marketing Requirements/Complaince: PMRs and PMCsDr. Reena Malik
This document discusses post-marketing requirements (PMRs) and post-marketing commitments (PMCs) required of drug sponsors after FDA approval. PMRs are studies required by regulation, while PMCs are studies agreed upon between the sponsor and FDA but not required. Sponsors must periodically report on the status of PMRs and PMCs, with certain details like enrollment required for clinical trials. The FDA provides guidance and websites for sponsors to report and check the status of post-marketing studies.
Regulatory requirnment and approval procedure of drugs in japan pptsandeep bansal
this ppt is about all the rules and regulations of drugs in Japan.this ppt contains the PMDA structure, DMF data, IND and NDA procedure, cosmetic regulations, post marketing survelliance etc.
Marketing Authorization Procedure in European UnionDoninder Hooda
The document discusses marketing authorization procedures in the European Union. It provides an overview of the general principles of marketing authorization and describes the key procedures including the national procedure, centralized procedure, mutual recognition procedure, and decentralized procedure. It outlines the mandatory and optional scopes of the various procedures and summarizes the timelines, responsibilities, and advantages and disadvantages of each authorization route.
The document discusses the electronic common technical document (eCTD) format for regulatory submissions to agencies like the FDA. It describes the structure of an eCTD, which includes five modules containing administrative information, summaries, quality details, nonclinical studies, and clinical studies. It also discusses the process of developing and submitting an eCTD, including using XML and PDF files. Regulatory agencies in countries like the US, EU, Japan and Canada accept eCTD submissions for applications like new drug applications.
7 Steps - How to Get a CE Marking Certification for Medical Devices?Puneet sharma
The document outlines the 7 steps to obtain CE marking certification for a medical device: 1) Classify the device, 2) Identify relevant standards and regulations, 3) Compile technical documentation and testing results, 4) Appoint a European authorized representative if located outside the EU, 5) Obtain certification from a notified body for class II/III devices or self-certify for class I, 6) Affix the CE marking, and 7) Comply with any national requirements. The service described can assist manufacturers with all aspects of the certification process.
Regulatory documents are required by health authorities before approval of new drugs, devices, or biologics. These documents include protocols, clinical study reports, investigator brochures, common technical documents, informed consent forms, and risk management plans. Protocols describe the study procedures and analysis plans. Clinical study reports integrate full study reports according to ICH guidelines. Investigator brochures provide safety information to investigators. Common technical documents assemble quality, safety, and efficacy data for regulatory submissions. Informed consent forms provide study information for participants. Risk management plans describe safety profiles and risk minimization plans.
clinical trial Management with ethics committeeSrinivasanBB
The document discusses key aspects of clinical trial management including experimental units, treatment and evaluation, approaches to clinical trials, the roles of various organizations, and essential documents. It provides definitions for experimental units and outlines how treatments and evaluations are conducted in clinical trials. It describes the trial approach process including principal investigators, feasibility questionnaires, ethics committee approval, and registration. It also outlines the roles of site management organizations, ethics committees in reviewing protocols and risks/benefits, and regulatory requirements in India including the Drug and Cosmetic Act, regulatory bodies, and the application process. Finally, it discusses important documents for conducting and reporting clinical trials.
The document discusses the European Drug Master File (EDMF), which was established in 1989-1991 and later revised in 2005. The EDMF, also known as an Active Substance Master File (ASMF), contains confidential manufacturing information that is divided into an applicant's part and a restricted part. The applicant's part is provided to marketing authorization applicants, while both parts are submitted to health authorities. The EDMF system aims to protect proprietary information while providing sufficient data to support drug approvals and ensure product quality.
This document discusses investigational device exemption (IDE) and post marketing surveillance. IDE allows investigational devices to be used in clinical studies to collect safety and effectiveness data, requiring approval by an institutional review board and FDA for significant risk devices. Post marketing surveillance monitors the safety of medical devices after market release using approaches like spontaneous reporting databases and patient registries to identify potential safety issues and provide long-term monitoring of effects. Both are important parts of ensuring device safety during development and after approval.
This document summarizes the objectives and classification system of the Global Harmonization Task Force (GHTF) for in vitro diagnostic (IVD) medical devices. The GHTF was founded in 1993 to harmonize medical device regulations globally. It aims to facilitate trade while preserving public health. IVD medical devices are classified into 4 risk-based classes (A to D) based on 16 general rules related to device invasiveness, energy use, and disease detection. Class A devices pose the lowest risk while Class D the highest. The classification system aims to ensure regulatory oversight is proportionate to device risk.
Clinical evaluation is the process of assessing clinical data to verify the safety and performance of a medical device for its intended use. It involves three main stages: 1) identifying existing clinical data from literature and reports, 2) appraising individual data sets for sufficiency, and 3) analyzing the overall strength of evidence and conclusions about safety and performance. If existing data is insufficient, new clinical evaluations must be conducted. A clinical evaluation report is prepared when existing data demonstrates conformity with essential requirements.
Planning and management of a clinical trial abroad Zeta Research
An Italian medical device manufacturer wanted to conduct a post-market clinical trial abroad to obtain marketing data quickly. A contract research organization proposed conducting the randomized controlled trial at an investigational site in an extra-EU country to maximize resources and expedite the 6-7 month timeline for analyzed data. The CRO planned to translate and adapt the study documents to local requirements, monitor the site, obtain ethics approval, manage products on site, and analyze data remotely according to good clinical practice to meet the client's goals in a cost-effective manner.
Developing strategies for contract adherence in medical devices cro contractsErik Vollebregt
This presentation was delivered at the Outsourcing in Clinical Trials: Medical Devices Europe 2016 conference in München on 17 February 2016. It covers do's and don'ts for CRO contracts in the medical devices sector.
Clinical Research Training - Dr Ruben Keane, UCC - Dec 7th 2016 ipposi
This document discusses current and future regulatory requirements for clinical trials in Ireland and Europe. Currently, clinical trials require approval from a research ethics committee and the Health Products Regulatory Authority. Substantial amendments and safety reporting are also regulated. The EU is introducing a new Clinical Trials Regulation that will streamline the approval process across countries using a single application system and coordinated review. This aims to increase harmonization, transparency and efficiency of conducting multinational clinical trials in Europe. Key details around implementing the new system in Ireland are still to be determined.
Report on the progress of NAAF’s Patient-Reported Outcome (PRO) Consortium to develop a single, consensus-defined PRO instrument that can be shared across industry partners and other ongoing initiatives to incorporate the voice of the patient in alopecia areata research.
The document outlines new regulatory requirements from ANMAT, the regulatory body in Argentina, for clinical pharmacology studies, including additional documentation required for authorization requests, good clinical practice standards, inspections of investigators, and changes in scope and forms. Key changes include stricter documentation standards, additional safety reporting requirements, and expanded authority for ANMAT to inspect sponsors and CROs in addition to investigators.
This document provides an overview of investigator initiated research (IIR). It defines what research is, discusses the importance of conducting research projects rather than just reading about them, and provides examples of simple studies using questionnaires. It discusses why research is important, what mindsets are most conducive to research, and how data can provide power and insights. The document then covers research impacts, types of clinical research, what constitutes a clinical trial, advantages and disadvantages of clinical trials, and requirements for investigators. It also discusses ethical principles in research, the protocol, research process, clinical research management resources, and MOH policies regarding research registration and approvals.
Introduction to Good Clinical Practice (GCP) Guidelines: Ensuring Quality in ...ClinosolIndia
Good Clinical Practice (GCP) guidelines are a set of international ethical and scientific standards that define the principles for designing, conducting, recording, and reporting clinical trials involving human participants. GCP guidelines provide a framework to ensure the safety, integrity, and quality of clinical research. Here is an introduction to GCP guidelines and their significance in ensuring quality in clinical research:
Purpose of GCP Guidelines: The primary purpose of GCP guidelines is to protect the rights, safety, and well-being of trial participants. GCP guidelines also aim to ensure the reliability and credibility of trial data, promoting the ethical conduct of clinical research and supporting the development of safe and effective medical interventions.
International Harmonization: GCP guidelines are developed and maintained by international regulatory and scientific organizations, including the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The ICH GCP guidelines are widely accepted and followed by regulatory authorities and the pharmaceutical industry globally.
Ethical Principles: GCP guidelines are rooted in ethical principles, including respect for the rights and autonomy of participants, minimizing risks, ensuring informed consent, protecting participant confidentiality, and maintaining impartiality and integrity in the conduct of clinical research.
Trial Design and Conduct: GCP guidelines provide recommendations for the design, conduct, and documentation of clinical trials. This includes protocols, study endpoints, inclusion/exclusion criteria, randomization procedures, blinding/masking, sample size determination, and statistical analysis plans. GCP emphasizes the need for scientific rigor, minimizing bias, and ensuring the validity of trial results.
Investigator Responsibilities: GCP guidelines outline the responsibilities of investigators and research staff involved in clinical trials. These responsibilities include obtaining informed consent from participants, conducting the trial in compliance with the protocol, ensuring participant safety, accurate and timely data collection and documentation, and maintaining source data integrity.
Institutional Review Board (IRB) Oversight: GCP guidelines emphasize the importance of independent ethical review and oversight of clinical trials by IRBs or ethics committees. IRBs ensure that the rights, safety, and well-being of trial participants are protected and that the trial design and conduct adhere to ethical principles and regulatory requirements.
Data Integrity and Documentation: GCP guidelines stress the importance of accurate, complete, and timely documentation of all trial-related activities and data. This includes the maintenance of essential documents, such as the protocol, informed consent forms, investigator's brochure, case report forms, and adverse event reports. GCP also emphasizes the need for data valida
In this PPt contain the E6 R1 and E6 R2 information , and the GCP training material for the Good prectice. and end of the ppt there is a ink which is use for your online training and generate certificate.
This document provides an overview of key considerations for preparing Investigational New Drug (IND) and Clinical Trial Authorization (CTA) submissions to regulatory agencies. It discusses essential pre-submission planning steps like defining roles and timelines. It also reviews the structure and content of IND and CTA applications, highlighting similarities and differences between FDA, EMA, MHRA, and Health Canada requirements. The document emphasizes strategies for improving efficiency in multi-country submissions, such as reusing common documents and templates across applications.
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This document summarizes the new requirements for clinical evaluations and investigations under the upcoming EU Medical Device Regulation (MDR). Some key points:
- The MDR introduces stricter rules for clinical evaluations and investigations that will require manufacturers to consult expert panels and provide more clinical data to demonstrate safety and performance.
- Clinical evaluations must generate and assess clinical data from the manufacturer's own investigations as well as data from competitors or pre-clinical tests.
- Clinical investigations will be mandatory for high-risk Class III devices and implantables, except under certain conditions where equivalence to existing devices can be shown.
- Notified bodies will have between 10-75 days to approve clinical evaluation reports and compliance with the new
IMS Health Clinical Trial Optimization SolutionsQuintilesIMS
IMS Health's Linda T. Drumright, general manager, Clinical Trial Optimization Solutions presents at the 3rd Annual Patient Recruitment & Retention Summit 2014 - San Francisco, CA
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This document provides an overview of plain language summaries (PLS) and a company's PLS program. It defines a PLS as a scientifically accurate, non-promotional translation of clinical trial results into easy-to-understand language. The document discusses the importance of sharing results with trial participants and investigators based on feedback from studies. It also reviews regulatory requirements for posting PLS, such as the EU Clinical Trials Regulation requiring posting within 1 year of study completion. Finally, it states that the company's PLS program information will be inserted to describe how it will implement PLS within timelines and any pilot studies.
This document discusses current and future innovation in the pharmaceutical industry from the perspective of Merck Research Laboratories. It outlines Merck's strategy to discover, develop, and bring innovative medicines to market by pursuing promising science, prioritizing key opportunities, and adapting to a changing landscape. Statistics are provided on Merck's 2018 clinical trial operations, and the relationships between product development teams, clinical sub-teams, and clinical trial teams. Considerations for clinical trial planning, site selection, and protocol design are examined. Pembrolizumab clinical development across many tumor types is reviewed, as are challenges developing a treatment for all genotypes of Hepatitis C.
- Patient recruitment for clinical trials is a major challenge, estimated to be a $1.2-1.8 billion market. Recruitment costs average 6% of trial costs and are a primary factor in delays.
- Less than 5% of patients are aware of clinical trials, and only 2-3% actually enroll. However, over 90% of participants have a positive experience and would participate again.
- There is significant opportunity to improve recruitment through more patient-centric approaches leveraging data, technology, and analytics to identify more eligible patients and improve the recruitment process. However, this will require changes to traditional models.
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What You Will Learn
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Separate SEND IG DART 1.1 from SEND IG
Manage legacy studies and studies that already meet requirements
Differentiate between submission packages
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Regulatory Affairs and Submissions Professionals
Pharmaceutical Data and Programming Professionals
Nonclinical/Preclinical Development Professionals
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Watch full webinar -
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2024 HIPAA Compliance Training Guide to the Compliance OfficersConference Panel
Join us for a comprehensive 90-minute lesson designed specifically for Compliance Officers and Practice/Business Managers. This 2024 HIPAA Training session will guide you through the critical steps needed to ensure your practice is fully prepared for upcoming audits. Key updates and significant changes under the Omnibus Rule will be covered, along with the latest applicable updates for 2024.
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Why Attend:
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Enroll Now to secure your spot in this crucial training session and ensure your HIPAA compliance is robust and audit-ready.
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Tobacco Use: Immediate effects include increased heart rate, while long-term risks encompass cancer and heart disease.
Drug Use: Risks vary depending on the drug type, including health and psychological implications.
Prevention Strategies: Education, healthy coping mechanisms, community support, and policies are vital in preventing substance use.
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Seeking Help for Addiction: Recognizing signs, available treatments, support systems, and resources are essential for recovery.
Personal Stories: Real stories of recovery emphasize hope and resilience.
Interactive Q&A: Engage the audience and encourage discussion.
Conclusion: Recap key points and emphasize the importance of awareness, prevention, and seeking help.
Resources: Provide contact information and links for further support.
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TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - ...rightmanforbloodline
TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - 34.
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TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - 34.
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This particular slides consist of- what is hypotension,what are it's causes and it's effect on body, risk factors, symptoms,complications, diagnosis and role of physiotherapy in it.
This slide is very helpful for physiotherapy students and also for other medical and healthcare students.
Here is the summary of hypotension:
Hypotension, or low blood pressure, is when the pressure of blood circulating in the body is lower than normal or expected. It's only a problem if it negatively impacts the body and causes symptoms. Normal blood pressure is usually between 90/60 mmHg and 120/80 mmHg, but pressures below 90/60 are generally considered hypotensive.
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Unlocking the Secrets to Safe Patient Handling.pdfLift Ability
Furthermore, the time constraints and workload in healthcare settings can make it challenging for caregivers to prioritise safe patient handling Australia practices, leading to shortcuts and increased risks.
Healthy Eating Habits:
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Tips for Healthy Eating: Offers practical advice such as incorporating a variety of foods, practicing moderation, staying hydrated, and eating mindfully.
Benefits of Regular Exercise:
Physical Benefits: Discusses how exercise aids in weight management, muscle and bone health, cardiovascular health, and flexibility.
Mental Benefits: Explains the psychological advantages, including stress reduction, improved mood, and better sleep.
Tips for Staying Active:
Encourages consistency, variety in exercises, setting realistic goals, and finding enjoyable activities to maintain motivation.
Maintaining a Balanced Lifestyle:
Integrating Nutrition and Exercise: Suggests meal planning and incorporating physical activity into daily routines.
Monitoring Progress: Recommends tracking food intake and exercise, regular health check-ups, and provides tips for achieving balance, such as getting sufficient sleep, managing stress, and staying socially active.
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Binaural hearing using two hearing aids instead of one offers numerous advantages, including improved sound localization, enhanced sound quality, better speech understanding in noise, reduced listening effort, and greater overall satisfaction. By leveraging the brain’s natural ability to process sound from both ears, binaural hearing aids provide a more balanced, clear, and comfortable hearing experience. If you or a loved one is considering hearing aids, consult with a hearing care professional at Ear Solutions hearing aid clinic in Mumbai to explore the benefits of binaural hearing and determine the best solution for your hearing needs. Embracing binaural hearing can lead to a richer, more engaging auditory experience and significantly improve your quality of life.
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EU CTR Compliance and Success Navigating Updates and Preparing Submissions for the EU CTIS Portal.pptx
1. EU CTR Compliance and Success
Navigating Updates and Preparing Submissions for EU CTIS Portal
2. Our Experts
Gina Bennett
Senior Clinical Trial
Transparency Specialist
5 years experience
Utkarsh Suhas Bartakke
Clinical Trial Transparency
Specialist
6 years' experience
Arshi Muhibulla Ghousia
Team Lead, Regulatory and
Medical Writing
10 Years
3. 3
Agenda
Topic Duration Presenter/s
Introduction 3 mins Gina
Navigating document updates: PLPS
- What we know so far – Regulation and Requirements
- Developing a PLPS – Content, Process and Timelines
- Challenges we faced
- Case study
15 mins Arshi
Preparing redacted submissions for CTIS portal
- Deferrals
- Challenges for Sponsors
- Case Studies
20 mins Gina and Utkarsh
Roadmap to successful CTIS submission 7 mins Gina
4. EU-CTR 536/2014 and CTIS
• The European Union Clinical Trials Regulation (No 536/2014) (EU
CTR) replaced the long-standing directive, the European Union
Clinical Trial Directive 2001/20/EC (EU CTD) on 31 January 2022
• The EU CTR aims at creating a favorable environment for
conducting interventional clinical trials in the EU with high
standards of safety for study participants and increased
transparency of clinical trial information
• Clinical Trial Applications (CTA) are submitted by the sponsor via
Clinical Trial Information System (CTIS) portal
• New Document Types within CTA requested under EU-CTR (e.g
PLPS)
• After decision is issued by MSC (Member State Concerned), lot of
clinical data is available to the public
(https://euclinicaltrials.eu/search-for-clinical-trials/)
• Sponsors protect data in two ways:
– Apply for Deferral
– Remove CCI and PPD
5. Poll Question
Have you applied for or provided support for a Clinical Trial application under
EU CTR?
Yes No
7. 7
What Do We Know So Far – Regulation and Requirements
for PLPS
Compliance with European
Union Clinical Trial
Registration 536/2014 (EU
CTR)
Portray details of clinical
study protocols while
eliminating most of the
technical language
Fastens the process of
recruitment and development
of lay summary results.
Public look into vital
information
Provides protocol
information of the study in
public domain in lay language
Used as a tool in clinical
research
8. 8
EMA vs MHRA Requirements for PLPS
MHRA requires
• ISRCTN registry
• PLPS of ~1000 words
EMA: Additional elements beyond EMA requirements would suggest below;
UK element Most similar EUCTIS element
Background and Study Aims Study rationale and objectives/endpoints
Who can participate? Trial population
What does the study involve? Trial design and Interventions
What are potential risks/benefits? Ethical considerations
EMA-European Medical Agency; ISRCTN-International Standard Randomised Controlled Trial Number; UK-United Kingdom; EUCTIS-European
Union Clinical Trial Information System; PLPS-Plain Language protocol Synopsis
9. 9
Background and Study Aims
Who can participate?
What does the study involve?
What are the possible benefits and risks of participating?
Where is the study run from?
Duration (Start and End Date)
Who is funding the study?
MHRA Requirements-PLPS Content
MHRA-Medicines and Healthcare products Regulatory Agency
10. Developing a PLPS: Points to Consider
• EU CT Number and Protocol Title
• Study rationale
• Primary and Secondary objectives and Endpoints
• Study Design
• Study Population
• Interventions
• Ethical considerations (benefit/risk assessment)
• Maximum of 2 pages
EU CT-European Union Clinical Trial
11. 11
How Different is PLPS from PIS?
PIS
• Longer Document
• Detailed Content (study details, patient details,
payment details, questionnaires etc)
PLPS
• 2 Page Document
• Concise content
PIS-Patient Information Sheet; PLPS-Plain Language Protocol Synopsis
12. 12
PLPS: Process and Timelines
SCP-Secure Copy of protocol
CTIS-Clinical Trial Information System
After approval
of a developed
Protocol
Create and
Approve PLPS
Redaction Translation Populate SCP
PLPS Authoring
request submitted,
writer support begins...
Hand off for
submission to CTIS
Week-19 Week-5 Week-3 Week-0
13. Equal to
2 pages
More than
2 pages
Less than
2 pages
Poll Question
What is the page limit for a PLPS as per EUCTR requirements?
14. • Quick turnover - Drafting in
few days
• Incomplete review due to
stringent timelines
Timelines
• Missing out on data which
would need PLPS amendment
• Complex clinical information to
be summarized in few pages
Data
• Many reviewers per functional
role, prolonged review time
• Delay in review
• Technical issue with the tool
• No back up resource for out of
office reviewers.
Stakeholders
Challenges We Faced!
15. Case Study: Authoring 5 PLPS for a CTIS Submission in
3 Weeks Timeline
• MMS was awarded with new
document type - PLPS
• Scope of work was to submit 5 PLPS
for same molecule in single
submission
• 5-day timeline, no room for round
table with reviewers
• Accommodate all the data from
protocol as per the template
instructions in 2 pages
• Lack of guidance on choosing
content from protocol
• Explaining Trial Design and population
in lay language
• Adding primary and secondary
objective and endpoints in concise
manner
Challenge
• Added expertise with lay language
along with crisp definitions of scales
for the endpoints
• Peer review to fine-tune the details
• Round the clock support to
complete the task
• Communication through emails and
follow ups for expedited review
• One-person approval was
implemented
• Worked on 4 documents in parallel
using the first approved PLPS as a
model.
Solution
• Delivered high quality PLPS(s) in 1
week of time and handover to the
Transparency team
• Complex study design with primary
and secondary endpoints (̴͂15-18) were
simplified using lay language
• Clinical information was
accommodated in 3-4 pages
• Repeat Business
Outcome
17. Transparency Regulations
17
• Protocol Data (Summary)
• Results Summary
• Clinical study reports
• Protocol
• SAP
• CRF (eCRF) sample
• Informed Consent (Optional)
EU CTR (CTIS) = Increased release of clinical documents to the public
• Protocol data (summary)
• Results summary
• Protocol
• SAP
• CRF template
• CSR body + synopsis + annexes
• + Interim results summary
• + Lay summaries
• + All Inspection Reports (worldwide)
• + Cover letter
• + Data safety monitoring committee charter
• +Scientific advice summary
• + Investigator’s brochure
• + Autorisation of manufacturing and import
• + QP GMP certification
• + IMPD and AMPD
• + Content labelling
• + Proof of payment of fee
• + Proof of insurance cover
• + Investigator CVs and the List of financial interests
• + Recruitment arrangements
• + informed consent
• +Audio/video advertisement
• + Statement of the suitability of the facilities
• + Statement of compliance to GDPR
Past Present
18. Poll Question
Do you prefer a deferral option or redactions to protect CCI in EU-CTIS
submissions?
Deferral Redaction for CCI
19. 19
Deferral Strategy
• Sponsors may apply for deferral of some documents during the CTIS submission of
their initial application to delay the publication of certain documents for a set time
based on the marketing authorization and phase of the trial
• For deferred documents, EMA expects little to no redaction related to CCIs
• Post deferral period, critical long standing CCI may still be considered CCI
Category 1
7 years of end of trial
Category 2
5 years of end of trial
Category 3 At MAA
decision, or within 1 year
of end of trial
20. 20
Deferral of Publication per Study Type
Category 1
(FIH, PK/PD, BE/BA, Bio similarity)
Category 2
(Phase II and III)
Category 3
(Phase IV)
Study protocol, PLPS 7 years after end of trial 5 years after end of trial
When summary of results are
made public
IMPD, IB 7 years after end of trial 5 years after end of trial
When summary of results are
made public
Subject information sheet 7 years after end of trial 5 years after end of trial Time of decision on trial
Request for Information (RFI) 7 years after end of trial 5 years after end of trial
When summary of results are
made public
Unexpected events, urgent
safety measures
When summary of results are
made public
At the designated time for publication for each notification type
Intermediate summary of
results
12 months after intermediate
analysis date (pediatric) or 30
months after end of trial
12 months after intermediate analysis date
Summary of results 6 months after intermediate
analysis date (pediatric) or 30
months after end of trial
6 months after end of trial (pediatric) or 12 months after end of trial
Layperson summary of results
CSR 30 days after marketing authorization decision, or 30 days after withdrawal of MAA
21. Any information contained in the clinical
documents submitted to the Agency by
the applicant/MAH that is not in the
public domain or publicly available and
where disclosure may undermine the
legitimate economic interest of the
applicant/MAH
CCI
Personal information about individuals
that encompasses both direct and
indirect identifiers that may increase the
risk of reidentification of an individual if
they are disclosed to the public
PPD
21
Protecting Non-Deferred Documents: PPD and CCI
• Excipients quantitative composition
• Synthesis/ manufacturing details of the active substance
• Future development plans
• New biomarkers or novel methodologies not yet qualified
• Innovative analytical methods
Indirect Identifiers
• Age
• Race and/or ethnicity
• Gender
Direct Identifiers
• Participant IDs
• Medical History
• Names/signatures
22. Common Pitfalls During Submission
22
Process
•Evolving regulation
•Document updates (SOPs, GD, WP)
•New document types
•Stakeholder management
Strict Timelines
•Request For Information (RFIs)
•Resource planning
Translation
•Vendor qualification
•Documents in-scope for translation
•Quality Certificates
CCI Handling
•Over-redaction
•Trainings
•Consistency across other submissions
of same drug molecule
23. 23
Process Considerations During CTIS Submission
Start is critical New set of documents
Collaboration within the
sponsor and vendor
teams
• Starting well in advance
• Scoping of documents-
Trackers-TOC-CCI trackers
• Working on Part I and II
documents simultaneously
• CTIS being a collaborative
effort, a streamlined work
transition between various
teams plays a key role.
• Roles, POC, and responsibilities
should be clearly
communicated
• Documents like PLPS, IB, DMC
charter etc getting published
in public domain
• Understanding the document
level CCI
• Work as per the criticality of
the document
24. 24
CCI Handling
Over redaction Lack of training
Co-relating Submissions
CTIS/P0070/HC
• Blanked redaction vs Targeted
redaction
• Study level vs Submission
level CCIs
• Once released on CTIS
unredacted no longer a CCI for
any other submission
• Temporary vs long term CCIs
• Training on CCI
• Public domain and Sponsor
document searches
• Stat team and IP Law team
CCI approaches
25. Case Study on Streamlining CCI Identification and Submission Process:
25
An Ongoing EU CTR Redaction Project from small pharma
• Helped sponsor with identification
of document types in-scope for CTIS
• Strategy support to identify
upcoming tasks for CTIS (transition
trials, prospective studies)
• Collaborated with sponsor on
necessary redactions by defining
PPD rulesets, QC checklists, CCI
tracker
Sponsor Unfamiliar with CTIS
Requirements
• MMS provided project management
support to sponsor
• Identified key responsibilities for
transparency team and sponsor
reviewers
• Aligned efficiencies to identify
standard and expedited timelines
Aid Sponsor With Ad-hoc
Resource Requirements
• Collaborated with sponsor experts
on identification of CCI
• Cross functional communication
between sponsor and MMS teams
for CCI alignment
• Understanding EMA criteria for CCI
acceptance based on deferral rules
Partner for CCI Handling
26. 26
Timelines for CTIS submissions
Over redaction Lack of training
Co-relating Submissions
CTIS/P0070/HC
• RFI response time is limited:
• 10 calendar days to
respond when received
during the validation
period
• 12 calendar days to
respond during Part I
and Part II assessment
periods
• Multiple rounds of RFI
• Authoring updates - Writing,
Biostats, Legal
• Submission updates -
Regulatory
• Redaction updates –
Transparency
• Translation updates –
Translation vendor
• Reducing timelines
• Expedited requests
• One person approvals
27. • Lack of resources to address the RFI
• Lack of expertise to track down the
changes and provide updated
documents
• received RFI over RFI
• Timeline was further reduced only
to a couple of days with subsequent
RFIs
Sponsor was unprepared for
RFIs
• MMS provided project management
support to sponsor
• Conducted RFI alignment meeting
• Alerted MMS global team
• Global team worked on the
document round the clock to get
the submission done on time
Aid Sponsor with timely
submission
• MMS carefully assessed the
situation to understand the RFI
requirements
• The time to response was as low
as 48 hours.
MMS a reliable partner
Case Study on RFI Support
A project on RFI responses for a sponsor with minimal experience in CTIS
27
28. 28
Translations Requirements for CTIS Submissions
Translation vendor
management
Identification of
documents
Quality certificates
• Active facilitator between
Sponsor and Translation
vendor
• Communication on document
requirements
• Timelines for translation
• Review of the documents
• Authenticity of the translation
• Successful audit
• Identification of the correct set
of documents (redaction
needed /not needed)
• Confirming with local sites for
availability of the translated
versions
• Multiple language
requirements of the document
29. Case Study on Translation of In-scope Documents
29
An EU CTR Redaction Project from sponsor dealing with first CTIS submission
• 1st submission
• 4 studies active simultaneously with
no prior information
• Expedited timelines
• Rush Services from translation
partner on a case-by-case basis
• No prior planning
Translation requirements with
no clear process
• MMS provided project management
support to sponsor
• Identified key process steps
between MMS/Translation partner
and sponsor.
• MMS helped to align the
communication between the
stakeholders, manage the process
and get the documents translated
on time.
MMS as a Liaison
• MMS scrutinized the in-scope
documents for actual translation
needs.
• Bringing down the number of
document for translation to only 3
from previously projected 160
documents in CTAs
• MMS helped the sponsor to save
significant cost on translation
services
Cost effective guidance
31. 31
CTIS submissions: A Collaborative Effort
Regulatory Operations
Sponsor
Data and
Documents
Regulatory
Strategy
Medical
Writing
Transparency
Translation
Vendor
Submission
Strategy,
countries
selection, data,
RFIs
Authoring and
Document
Generation
Public
Anonymized
Document
Generation
Translation of
Original and
Anonymized
Documents
Content Plan, Document Publishing,
CTA Compilation, QC, and submission
Sponsor
Review and
Approval
32. 32
Utilizing Cross Functional Teams to Streamline Processes
• Regulatory Affairs to guide sponsor on document submission
– Develops better understanding of process and what is needed when uploading these
documents to the portal
– Help make transitions for sponsors better
• Medical writers knowledgeable in “lean writing”
– Educate submission medical writers on PPD and CCI and how to avoid when authoring
documents:
– Limit the amount of necessary CCI
– If possible, refrain from adding any unpublished information
– Refrain from adding any PPD such as subject IDs
33. 33
Utilizing Cross Functional Teams to Streamline Processes
• Transparency to educate Sponsors on protection of CCI and PPD
– Identification of temporary vs long standing CCI
• Data can be maintained on an electronic database; sponsor can start making
a list of the documents and keep them ready to upload well in advance of
the submission
– Ideal time would be three months in advance to begin the redaction
work and assessment of the documents
– The documents can be prioritized as per the page and data complexity
Thank you for the introductions. Our team is excited to share our experiences with EU CTR CTIS submissions. For those who may be somewhat unfamiliar , EU CTR stands for the European Union Clinical Trials Regulation which began replacing the former EU CTD or European Union Clinical Trial Directive on Jan 31 2022. Sponsors had one year to take part in voluntary submissions under the new regulation before it became required of all sponsors submitting new trial applications as of January 31 2023
EU CTR is a searchable public website that aims at creating a more favorable environment for conducting interventional trials in the EU with high standards of safety for study participants and increased transparency of clinical trial information
Before we move on, let’s take a minute to conduct a quick poll to find out how many of you attending today have provided support in any fashion for a Clinical trial application under EU CTR? We will pause and give everyone a chance to respond.
Thank you for your responses….
Today, we want to focus on the role of Transparency as well as interdepartmental collaboration in EU CTR submissons. Let’s begin with why and how it is important to protect your trial data
EU Clinical Trial Regulation that went live on January 31st, 2022. It’s Clinical Trials Information System (CTIS) is being presented as a one-stop shop for clinical trial applications, regulatory review, and public access to trial information.
For the first year of rollout, stakeholders can use CTIS, but existing application frameworks will still exist. From January 2023, all new clinical trial applications will go through CTIS. Beginning 2025, all new and ongoing trials must go through the platform.
What is the impact for Transparency? More clinical trial documents will be made public.
EU-CTR 536/2014 is to provide a single, unified portal and database, which is the Clinical Trials Information System (CTIS), available for both trial sponsors and regulatory authorities of each Member State. The CTIS will be a centralized, paperless, integrated, single-entry point for submission, evaluation of data, authorizing, supervising, and reporting any trial-related information between the relevant Member States. The EMA will set up and manage the CTIS, in collaboration with the Member States and the European Commission.{5} The purpose of this system is to considerably facilitate the process of clinical trial conduct across EU, starting from the initial submission to authorization, providing corrective measures, inspection information, and publication of relevant documents for the general public. It’s use will be mandatory for new clinical trials after January 31, 2022 with a one year transition period where applicants can choose to file under the existing clinical trials directive or under the new regulation.
Before we move on, let’s take a minute to conduct a quick poll to find out how many of you attending today have provided support in any fashion for a Clinical trial application under EU CTR? We will pause and give everyone a chance to respond.
Thank you for your responses….
So, what is deferral?
Sponsors may apply for deferral of some documents during the submission of their initial application
Deferral delays the publication of certain documents for a set time period based on the marketing authorization and phase of the trial
For deferred documents, CTIS expects little to no redaction
Only PPD and very limited pieces of critical long standing CCI that may still be considered CCI after the deferral period has lapsed
CTIS quote: Using simultaneously both CCI redaction and deferral requests for the same document, or set of documents, equates to over redaction and would not be acceptable. In this context it is acknowledged that, in limited situations, some pieces of information (of quality nature in the trial protocol, for example) may still be considered CCI even after the deferral period elapses and consequently would be redacted even in documents subject to deferral requests.
Not all documents can be deferred. This table from this slide is taken from EMA EU CTR guidance and outlines what documents fall under this option:
See table
The category and phase of the trial also play into how long the deferral period may last
Category 1: pharmaceutical development trials
Category 2: therapeutic exploratory and confirmatory trials
Category 3: therapeutic use trials
Another way to protect your data in all submitted documents is the use of redaction;
PPD (read slide definition) and includes indirect identifiers such as (age, race/ethnicity and gender to name a few) and Direct identifiers such as participant IDs, safety case numbers, names and handwritten signatures to name a few)
Here you see what the redacted overlay for PPD would look like in the public domain
CCI (read definition) this could include any of the following (read banner) as a few examples
This process flow depicts the functional lines integration that is needed for CTIS. Data and Documents are collected from the sponsor. RO will drive the submission process that typically includes content plan creation, data and document collection, document publishing and submission related activities such as compilation, QC, and dispatching.
As any other regulatory submission, we’ll need to do this hand-in-hand with RS team with inputs on submission such as countries selection, data, and responses to RFIs. Partner with MW on procuring the correct document and any responses to RFIs. Transparency is built into the design with CTIS. As you have heard multiple times today most data and documents will be made publicly available one time or the other. Hence coordination with TS team on public/anonymized documents will be needed at each and every step of the submission. Lastly, we will also be able to coordinate the translation of documents with our preferred vendor.
Most Part I documents can be accepted in English
Missing RFI deadlines may result in the CTA being deemed as lapsed and an automatic withdrawal of the application in all Member States
Identifying CCI in clinical data can bring its own unique set of challenges and is something that as transparency experts we should take time to educate Sponsors about best practices. Some of our best practice tips include:
(bullet points on slide)
Public Domain Searches
- European Public Assessment Reports
- FDA Summary Basis of Approval, Advisory Committee materials
- Trial registries (eg, ClinicalTrials.gov, EudraCT), company websites etc.
Sponsor Publications
- Abstracts, posters and journal articles etc.
- Documents/publications available with the sponsor to be shared with the transparency team. This helps to locate CCI quickly.
31 January 2023 : All new initial clinical trial applications became subject to EU CTR