This document summarizes clinical trial inspection procedures conducted by ANMAT, the regulatory agency in Argentina. It outlines the selection criteria for inspections, communication procedures, documentation to be reviewed including informed consent forms, and requirements for on-site inspection reports. Inspections aim to ensure compliance with regulations and protect participant safety. Inspectors have authority to interrupt studies if serious risks are identified. Inspected parties have an opportunity to address any findings or provide clarifications. Inspection results are classified as No Action Indicated, Voluntary Action Indicated, or Official Action Indicated depending on the issues found.
Latest update Brazil Regulations By S. Jaime - Qserve Group (Qserve Conferen...qserveconference2013
The document discusses regulations for medical devices in Brazil, including the country's healthcare system and regulatory approval process. It outlines key steps such as classification, appointing a Brazilian registration holder, ANVISA GMP inspection, INMETRO certification, and ANVISA registration. The lengthy overall process and importance of understanding regulatory changes and working with a local partner are emphasized.
ANVISA is the Brazilian Health Surveillance Agency that regulates health products and services. It oversees the registration, labeling, and safety monitoring of drugs, medical devices, cosmetics, food, and other products. ANVISA also regulates blood and tissue donation, health services, pesticides, and tobacco. It aims to protect public health through rules, inspections, and international cooperation.
the ppt describes in detail the translational research and path of the drug from lab to bed side, CONSORT guidelines, DCGI guidelines, CTR-I, the GCP principles, medical ethics, sample size estimation for RCT, RCT designs including cross over design and factorial design, Randomized permuted blocks, blinding and matching.
Kassa Ayalew FDA Perspective on FCTs 2016_0 (1).pptxSapnaAkhani
This document discusses international clinical trials and challenges with foreign data submitted to the FDA. It provides an overview of FDA regulations regarding acceptance of foreign data, considerations for international inspections, and challenges including limited inspection resources relative to the number of foreign sites. The document addresses these challenges by leveraging knowledge through risk-based site selection, international collaborations, and encouraging sponsors to utilize data standards.
summary report of inspections of clinical trials conducted from April 2004 to...mahmoudnasseri
This document summarizes Health Canada inspections of clinical trials conducted from 2004 to 2011. During this period, 329 inspections found 3148 observations of non-compliance, mostly related to quality systems/procedures and record keeping. 92% of inspections were rated compliant and 8% non-compliant. Common deficiencies included lack of standard operating procedures, inadequate documentation and personnel training. The report aims to increase awareness of regulatory requirements and improve compliance for protecting clinical trial participants.
Clinical trial inspection programme of indiaitsaruns
This document provides guidance on conducting clinical trial inspections. It outlines objectives to verify GCP compliance, credibility of data, and compliance with regulations. It describes planning inspections, including study selection, preparation, and scheduling. Procedures for inspecting clinical trial sites and sponsor/CRO facilities are covered, examining documentation, organization, product accountability, and ethics compliance. The goal is to safeguard participants and ensure integrity and oversight of clinical research.
Good laboratory practices (GLP) were established in the 1970s after fraudulent data was submitted to the FDA from toxicology laboratories. The key case involved Industrial Bio-Test Laboratories, which falsified safety tests. This led the FDA to create GLP regulations in 1978 to ensure non-clinical study data quality and integrity. The OECD later established universal GLP principles in 1981 to facilitate international acceptance of study data. GLP provides standards for test facility organization and quality management, facilities, test system handling, study conduct, reporting, and record keeping to ensure study data accurately represent results. India has established a National GLP Compliance Monitoring Authority to oversee adherence to GLP standards by domestic testing facilities.
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.
Latest update Brazil Regulations By S. Jaime - Qserve Group (Qserve Conferen...qserveconference2013
The document discusses regulations for medical devices in Brazil, including the country's healthcare system and regulatory approval process. It outlines key steps such as classification, appointing a Brazilian registration holder, ANVISA GMP inspection, INMETRO certification, and ANVISA registration. The lengthy overall process and importance of understanding regulatory changes and working with a local partner are emphasized.
ANVISA is the Brazilian Health Surveillance Agency that regulates health products and services. It oversees the registration, labeling, and safety monitoring of drugs, medical devices, cosmetics, food, and other products. ANVISA also regulates blood and tissue donation, health services, pesticides, and tobacco. It aims to protect public health through rules, inspections, and international cooperation.
the ppt describes in detail the translational research and path of the drug from lab to bed side, CONSORT guidelines, DCGI guidelines, CTR-I, the GCP principles, medical ethics, sample size estimation for RCT, RCT designs including cross over design and factorial design, Randomized permuted blocks, blinding and matching.
Kassa Ayalew FDA Perspective on FCTs 2016_0 (1).pptxSapnaAkhani
This document discusses international clinical trials and challenges with foreign data submitted to the FDA. It provides an overview of FDA regulations regarding acceptance of foreign data, considerations for international inspections, and challenges including limited inspection resources relative to the number of foreign sites. The document addresses these challenges by leveraging knowledge through risk-based site selection, international collaborations, and encouraging sponsors to utilize data standards.
summary report of inspections of clinical trials conducted from April 2004 to...mahmoudnasseri
This document summarizes Health Canada inspections of clinical trials conducted from 2004 to 2011. During this period, 329 inspections found 3148 observations of non-compliance, mostly related to quality systems/procedures and record keeping. 92% of inspections were rated compliant and 8% non-compliant. Common deficiencies included lack of standard operating procedures, inadequate documentation and personnel training. The report aims to increase awareness of regulatory requirements and improve compliance for protecting clinical trial participants.
Clinical trial inspection programme of indiaitsaruns
This document provides guidance on conducting clinical trial inspections. It outlines objectives to verify GCP compliance, credibility of data, and compliance with regulations. It describes planning inspections, including study selection, preparation, and scheduling. Procedures for inspecting clinical trial sites and sponsor/CRO facilities are covered, examining documentation, organization, product accountability, and ethics compliance. The goal is to safeguard participants and ensure integrity and oversight of clinical research.
Good laboratory practices (GLP) were established in the 1970s after fraudulent data was submitted to the FDA from toxicology laboratories. The key case involved Industrial Bio-Test Laboratories, which falsified safety tests. This led the FDA to create GLP regulations in 1978 to ensure non-clinical study data quality and integrity. The OECD later established universal GLP principles in 1981 to facilitate international acceptance of study data. GLP provides standards for test facility organization and quality management, facilities, test system handling, study conduct, reporting, and record keeping to ensure study data accurately represent results. India has established a National GLP Compliance Monitoring Authority to oversee adherence to GLP standards by domestic testing facilities.
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.
Digital Scholar Webinar: Understanding and using PROSPERO: International pros...SC CTSI at USC and CHLA
This 60-minute webinar starts with an overview of why and how PROSPERO was developed. I will then show how to search the database and how to register systematic review protocol details and keep records up to date. Reflections on the 10 years since the launch of PROSPERO and the challenges the rapidly changing digital environment now presents will also be briefly covered.
Speaker
Dr. Alison Booth Senior Research Fellow, University of York, UK
Dr. Booth joined the York Trials Unit (YTU) in October 2015. She has experience in the design and conduct of a range of research methods, in particular systematic reviews, RCTs, and methodological studies. She has a background in radiography, clinical governance and research ethics. Alison is a Senior Research Fellow in YTU and also an Advisor and Impact Lead for the NIHR Research Design Service Yorkshire and Humber (RDS YH). Her particular interests are in knowledge translation, impact and transparency in research reporting.
The document discusses clinical trials registries and the Clinical Trials Registry-India (CTRI). It describes how CTRI was established to increase transparency and accessibility of clinical trial data in India. It provides details on CTRI's mission and dataset, requirements for trial registration, and its role as a primary registry that collects and shares data according to WHO guidelines.
Good Laboratory Practices, Protocol, Contents of protocol, Conduct of a non-clinical laboratory study, Reporting of non-clinical laboratory study results,
Clinical Trial Registration
International Clinical Trials Registry Platform (ICTRP)
What is the Primary Register?
Clinical Trial Registry - India (CTRI)
Goal and Objectives of the Registry
How to Register?
Good laboratory practice guidelines. GLP IN INDIA. selvaraj227
The document discusses Good Laboratory Practice (GLP) guidelines. It provides an introduction to GLP, including that GLP deals with how laboratory studies are planned, performed, monitored and reported to ensure quality and validity of test data. The history and purpose of GLP are then outlined, noting it was established to prevent fraud and promote standardized, high-quality non-clinical safety testing. Ten GLP principles are also summarized, covering topics like facilities, equipment and management responsibilities. Finally, the scope and current status of GLP in India are briefly addressed.
The document discusses Good Laboratory Practices (GLP), which are regulations created by the FDA in 1978 that provide a framework for conducting laboratory studies. GLP was established in response to cases of poor laboratory practices including fraudulent activities and inaccurate reporting of results. The objectives of GLP are to ensure data submitted accurately reflects study results and is traceable. Laboratories must comply with standards for facilities, equipment, record-keeping, personnel qualifications and quality control to avoid penalties for noncompliance like disqualification and inability to conduct future studies.
The document discusses Good Laboratory Practices (GLP), which are regulations created by the FDA in 1978 that provide a framework for conducting laboratory studies. GLP was established in response to cases of poor laboratory practices including fraudulent activities and inaccurate reporting of results. The objectives of GLP are to ensure data submitted accurately reflects study results and is traceable. Laboratories must comply with requirements around facilities, equipment, recordkeeping, personnel qualifications and standard operating procedures to adhere to GLP. Noncompliance can result in disqualification and civil or criminal penalties for the laboratory.
1) The document discusses Good Laboratory Practices (GLP), which are international standards for conducting non-clinical health and environmental safety studies established by the Organization for Economic Cooperation and Development.
2) GLP were created in response to malpractices in laboratories such as falsifying data and fabricating test results. GLP aim to ensure data integrity and quality.
3) Key aspects of GLP include having a Quality Assurance unit to monitor compliance, detailed study protocols, animal housing and care controls, and documentation standards for reports and record retention. GLP implementation leads to mutually accepted data while ensuring public confidence.
GLP (Good Laboratory Practice) is a quality system concerned with the organization and conditions under which non-clinical health and environmental safety studies are conducted. It was instituted in the US after fraudulent data was submitted by toxicology labs to the FDA. The OECD then established principles of GLP to harmonize standards internationally. The key principles cover organization and personnel, quality assurance, facilities, equipment, test systems, study conduct, reporting and record keeping. Compliance ensures the validity and integrity of study data submitted to regulatory authorities like the FDA. India has a National GLP Compliance Monitoring Authority that inspects and certifies laboratories according to OECD GLP principles.
It is difficult to maintain the sterility and It is more difficult to investigate when the status is Non sterile. So this ppt narrate the way for you to investigate the Non sterility.
The presentation deals with the hot issues of regulatory violations made by the Ranbaxy in Mohali plant. It has the violations made and the observations of the FDA inspector, also gives a basic overview of what is form 483 and consent decree. The CAPA I will be uploading soon enough.
GLP (Good Laboratory Practice) is a quality system for non-clinical health and environmental safety studies. It was instituted in the US after fraudulent data was submitted by toxicology labs. GLP aims to ensure studies are properly planned, monitored, and reported, and that data accurately reflects results. It promotes international acceptance of safety tests. The OECD principles provide an international standard for GLP, covering topics like facility organization, test system and item characterization, and record keeping. India has established a National GLP Compliance Monitoring Authority to oversee GLP standards.
Good clinical practices tutorial- v7.015--shehnaz_june-10_v 3.0Shehnaz Vakharia
- The document discusses regulatory issues related to conducting clinical trials in India, including the regulatory framework, applicable local regulations, advantages of conducting trials in India, and key challenges.
- Some advantages include reasonable regulatory approvals, high incidence of diseases common in Western countries, large treatment-naïve populations, and English as the primary business language.
- However, challenges include a shortage of GCP-trained investigators, documentation practices like back-dating records, busy investigator schedules, and variable infrastructure across sites.
Laura Shawver is a clinical research coordinator with over 30 years of experience in ophthalmology clinical trials. She has extensive experience coordinating trials for various ocular conditions including uveitis, macular degeneration, and diabetic macular edema. She is certified as a CCRP and COT and has coordinated trials for many pharmaceutical companies. She currently works as a clinical research coordinator while seeking a new position in medical research.
Good Laboratory Practice (GLP) regulations were created by the FDA in 1978 to ensure the quality and integrity of nonclinical safety data from laboratories. GLP provides a framework for how nonclinical studies are planned, performed, monitored, recorded, and reported. They apply to safety studies of products that are regulated by the FDA and EPA, such as pharmaceuticals, pesticides, and industrial chemicals. GLP regulations have since been adopted internationally through the OECD and individual countries to harmonize standards globally.
End of Internship Presentation Slides (Geomatika University College)Darshini Perumalsivam
Overall, this internship was a useful experience. I have gained new knowledge, skills and met many new people. I achieved several of my learning goals, however for some the conditions did not permit.
Throughout my internship, I could understand more about the definition of Good Clinical Practice and the way of applying it in the Clinical Study as well as the importance of Drug Regulation. This provide me to prepare myself to become a responsible and an ambitious Clinical Research Associate (CRA) in the future. Along my training period, I realise that observation and time management is a main element in order to identify and to complete the study.
During the task assigned, I corporate with my colleagues to determine the problems. This indirectly helped me to learn independently, discipline myself, be considerate/ patient, self-trust, take initiative and ability to solve problems. Besides, my communication skill is strengthened as well when communicating with others. During training period, I have received advices from supervisors and colleagues when mistakes were made. Those advices are useful guidance for me to change myself and avoid myself making the same mistakes again.
In sum, the activities and tasks assigned that I have done as well as learned during my industrial training are really useful for me in future to face challenges in a working environment.
The mission of the Clinical Trials Registry-India (CTRI) is to ensure that all clinical trials conducted in India are prospectively registered, i.e. before the enrolment of the first participant. Additionally, post-marketing surveillance studies, BA/BE studies as well as clinical studies as part of PG thesis are also expected to be registered in the CTRI. The vision of the CTRI is to ensure that every clinical trial conducted in the region is prospectively registered with full disclosure of the trial data set items. While this register is meant primarily for trials conducted in India, the CTRI will also accept registration of trials conducted in other countries in the region, which do not have a Primary Registry of its own, provided ethics approval (in English) is available and the study has not begun enrolling. The Clinical Trials Registry- India (CTRI), hosted at the ICMR's National Institute of Medical Statistics (http://icmr-nims.nic.in), is a free and online public record system for registration of clinical trials being conducted in India that was launched on 20th July 2007 (www.ctri.nic.in). Initiated as a voluntary measure, since 15th June 2009, trial registration in the CTRI has been made mandatory by the Drugs Controller General (India) (DCGI) (www.cdsco.nic.in). Moreover, Editors of Biomedical Journals of 11 major journals of India declared that only registered trials would be considered for publication1, 2.
Today, any researcher who plans to conduct a trial involving human participants, of any intervention such as drugs, surgical procedures, preventive measures, lifestyle modifications, devices, educational or behavioral treatment, rehabilitation strategies as well as trials being conducted in the purview of the Department of AYUSH (http://indianmedicine.nic.in/) is expected to register the trial in the CTRI before enrollment of the first participant. Trial registration involves public declaration and identification of trial investigators, sponsors, interventions, patient population etc before the enrollment of the first patient. Submission of Ethics approval and DCGI approval (if applicable) is essential for trial registration in the CTRI. Multi-country trials, where India is a participating country, which have been registered in an international registry, are also expected to be registered in the CTRI. In the CTRI, details of Indian investigators, trial sites, Indian target sample size and date of enrollment are captured. After a trial is registered, trialists are expected to regularly update the trial status or other aspects as the case may be. After a trial is registered, all updates and changes will be recorded and available for public display.
Siro Clinical Research Institute
Post Graduate Diploma in Clinical Research
www.siroinstitute.com
www.siroclinpharm.com
1) The document outlines procedures for validating laboratory test results prior to reporting at Hilongos District Hospital.
2) It describes validation processes for specimens in the pre-analytical, analytical, and post-analytical phases to ensure accuracy of results.
3) Key steps include checking request forms, specimen handling, testing methods, result reporting, and notifying clinicians of critical results.
United States Diagnostics Market Size, Share, Trend and Forecast 2026 | TechS...TechSci Research
According to #TechSci Research report, United States Diagnostics Market stood at USD30.08billion in 2020 and is expected to grow at a steady rate of 5.17% during the forecast period.
Gain More Insight: https://bit.ly/3wWI0do
Get Sample Report: https://bit.ly/3ltFdo6
Website: https://www.techsciresearch.com/
Market Research News: https://techsciblog.com/
Digital Scholar Webinar: Understanding and using PROSPERO: International pros...SC CTSI at USC and CHLA
This 60-minute webinar starts with an overview of why and how PROSPERO was developed. I will then show how to search the database and how to register systematic review protocol details and keep records up to date. Reflections on the 10 years since the launch of PROSPERO and the challenges the rapidly changing digital environment now presents will also be briefly covered.
Speaker
Dr. Alison Booth Senior Research Fellow, University of York, UK
Dr. Booth joined the York Trials Unit (YTU) in October 2015. She has experience in the design and conduct of a range of research methods, in particular systematic reviews, RCTs, and methodological studies. She has a background in radiography, clinical governance and research ethics. Alison is a Senior Research Fellow in YTU and also an Advisor and Impact Lead for the NIHR Research Design Service Yorkshire and Humber (RDS YH). Her particular interests are in knowledge translation, impact and transparency in research reporting.
The document discusses clinical trials registries and the Clinical Trials Registry-India (CTRI). It describes how CTRI was established to increase transparency and accessibility of clinical trial data in India. It provides details on CTRI's mission and dataset, requirements for trial registration, and its role as a primary registry that collects and shares data according to WHO guidelines.
Good Laboratory Practices, Protocol, Contents of protocol, Conduct of a non-clinical laboratory study, Reporting of non-clinical laboratory study results,
Clinical Trial Registration
International Clinical Trials Registry Platform (ICTRP)
What is the Primary Register?
Clinical Trial Registry - India (CTRI)
Goal and Objectives of the Registry
How to Register?
Good laboratory practice guidelines. GLP IN INDIA. selvaraj227
The document discusses Good Laboratory Practice (GLP) guidelines. It provides an introduction to GLP, including that GLP deals with how laboratory studies are planned, performed, monitored and reported to ensure quality and validity of test data. The history and purpose of GLP are then outlined, noting it was established to prevent fraud and promote standardized, high-quality non-clinical safety testing. Ten GLP principles are also summarized, covering topics like facilities, equipment and management responsibilities. Finally, the scope and current status of GLP in India are briefly addressed.
The document discusses Good Laboratory Practices (GLP), which are regulations created by the FDA in 1978 that provide a framework for conducting laboratory studies. GLP was established in response to cases of poor laboratory practices including fraudulent activities and inaccurate reporting of results. The objectives of GLP are to ensure data submitted accurately reflects study results and is traceable. Laboratories must comply with standards for facilities, equipment, record-keeping, personnel qualifications and quality control to avoid penalties for noncompliance like disqualification and inability to conduct future studies.
The document discusses Good Laboratory Practices (GLP), which are regulations created by the FDA in 1978 that provide a framework for conducting laboratory studies. GLP was established in response to cases of poor laboratory practices including fraudulent activities and inaccurate reporting of results. The objectives of GLP are to ensure data submitted accurately reflects study results and is traceable. Laboratories must comply with requirements around facilities, equipment, recordkeeping, personnel qualifications and standard operating procedures to adhere to GLP. Noncompliance can result in disqualification and civil or criminal penalties for the laboratory.
1) The document discusses Good Laboratory Practices (GLP), which are international standards for conducting non-clinical health and environmental safety studies established by the Organization for Economic Cooperation and Development.
2) GLP were created in response to malpractices in laboratories such as falsifying data and fabricating test results. GLP aim to ensure data integrity and quality.
3) Key aspects of GLP include having a Quality Assurance unit to monitor compliance, detailed study protocols, animal housing and care controls, and documentation standards for reports and record retention. GLP implementation leads to mutually accepted data while ensuring public confidence.
GLP (Good Laboratory Practice) is a quality system concerned with the organization and conditions under which non-clinical health and environmental safety studies are conducted. It was instituted in the US after fraudulent data was submitted by toxicology labs to the FDA. The OECD then established principles of GLP to harmonize standards internationally. The key principles cover organization and personnel, quality assurance, facilities, equipment, test systems, study conduct, reporting and record keeping. Compliance ensures the validity and integrity of study data submitted to regulatory authorities like the FDA. India has a National GLP Compliance Monitoring Authority that inspects and certifies laboratories according to OECD GLP principles.
It is difficult to maintain the sterility and It is more difficult to investigate when the status is Non sterile. So this ppt narrate the way for you to investigate the Non sterility.
The presentation deals with the hot issues of regulatory violations made by the Ranbaxy in Mohali plant. It has the violations made and the observations of the FDA inspector, also gives a basic overview of what is form 483 and consent decree. The CAPA I will be uploading soon enough.
GLP (Good Laboratory Practice) is a quality system for non-clinical health and environmental safety studies. It was instituted in the US after fraudulent data was submitted by toxicology labs. GLP aims to ensure studies are properly planned, monitored, and reported, and that data accurately reflects results. It promotes international acceptance of safety tests. The OECD principles provide an international standard for GLP, covering topics like facility organization, test system and item characterization, and record keeping. India has established a National GLP Compliance Monitoring Authority to oversee GLP standards.
Good clinical practices tutorial- v7.015--shehnaz_june-10_v 3.0Shehnaz Vakharia
- The document discusses regulatory issues related to conducting clinical trials in India, including the regulatory framework, applicable local regulations, advantages of conducting trials in India, and key challenges.
- Some advantages include reasonable regulatory approvals, high incidence of diseases common in Western countries, large treatment-naïve populations, and English as the primary business language.
- However, challenges include a shortage of GCP-trained investigators, documentation practices like back-dating records, busy investigator schedules, and variable infrastructure across sites.
Laura Shawver is a clinical research coordinator with over 30 years of experience in ophthalmology clinical trials. She has extensive experience coordinating trials for various ocular conditions including uveitis, macular degeneration, and diabetic macular edema. She is certified as a CCRP and COT and has coordinated trials for many pharmaceutical companies. She currently works as a clinical research coordinator while seeking a new position in medical research.
Good Laboratory Practice (GLP) regulations were created by the FDA in 1978 to ensure the quality and integrity of nonclinical safety data from laboratories. GLP provides a framework for how nonclinical studies are planned, performed, monitored, recorded, and reported. They apply to safety studies of products that are regulated by the FDA and EPA, such as pharmaceuticals, pesticides, and industrial chemicals. GLP regulations have since been adopted internationally through the OECD and individual countries to harmonize standards globally.
End of Internship Presentation Slides (Geomatika University College)Darshini Perumalsivam
Overall, this internship was a useful experience. I have gained new knowledge, skills and met many new people. I achieved several of my learning goals, however for some the conditions did not permit.
Throughout my internship, I could understand more about the definition of Good Clinical Practice and the way of applying it in the Clinical Study as well as the importance of Drug Regulation. This provide me to prepare myself to become a responsible and an ambitious Clinical Research Associate (CRA) in the future. Along my training period, I realise that observation and time management is a main element in order to identify and to complete the study.
During the task assigned, I corporate with my colleagues to determine the problems. This indirectly helped me to learn independently, discipline myself, be considerate/ patient, self-trust, take initiative and ability to solve problems. Besides, my communication skill is strengthened as well when communicating with others. During training period, I have received advices from supervisors and colleagues when mistakes were made. Those advices are useful guidance for me to change myself and avoid myself making the same mistakes again.
In sum, the activities and tasks assigned that I have done as well as learned during my industrial training are really useful for me in future to face challenges in a working environment.
The mission of the Clinical Trials Registry-India (CTRI) is to ensure that all clinical trials conducted in India are prospectively registered, i.e. before the enrolment of the first participant. Additionally, post-marketing surveillance studies, BA/BE studies as well as clinical studies as part of PG thesis are also expected to be registered in the CTRI. The vision of the CTRI is to ensure that every clinical trial conducted in the region is prospectively registered with full disclosure of the trial data set items. While this register is meant primarily for trials conducted in India, the CTRI will also accept registration of trials conducted in other countries in the region, which do not have a Primary Registry of its own, provided ethics approval (in English) is available and the study has not begun enrolling. The Clinical Trials Registry- India (CTRI), hosted at the ICMR's National Institute of Medical Statistics (http://icmr-nims.nic.in), is a free and online public record system for registration of clinical trials being conducted in India that was launched on 20th July 2007 (www.ctri.nic.in). Initiated as a voluntary measure, since 15th June 2009, trial registration in the CTRI has been made mandatory by the Drugs Controller General (India) (DCGI) (www.cdsco.nic.in). Moreover, Editors of Biomedical Journals of 11 major journals of India declared that only registered trials would be considered for publication1, 2.
Today, any researcher who plans to conduct a trial involving human participants, of any intervention such as drugs, surgical procedures, preventive measures, lifestyle modifications, devices, educational or behavioral treatment, rehabilitation strategies as well as trials being conducted in the purview of the Department of AYUSH (http://indianmedicine.nic.in/) is expected to register the trial in the CTRI before enrollment of the first participant. Trial registration involves public declaration and identification of trial investigators, sponsors, interventions, patient population etc before the enrollment of the first patient. Submission of Ethics approval and DCGI approval (if applicable) is essential for trial registration in the CTRI. Multi-country trials, where India is a participating country, which have been registered in an international registry, are also expected to be registered in the CTRI. In the CTRI, details of Indian investigators, trial sites, Indian target sample size and date of enrollment are captured. After a trial is registered, trialists are expected to regularly update the trial status or other aspects as the case may be. After a trial is registered, all updates and changes will be recorded and available for public display.
Siro Clinical Research Institute
Post Graduate Diploma in Clinical Research
www.siroinstitute.com
www.siroclinpharm.com
1) The document outlines procedures for validating laboratory test results prior to reporting at Hilongos District Hospital.
2) It describes validation processes for specimens in the pre-analytical, analytical, and post-analytical phases to ensure accuracy of results.
3) Key steps include checking request forms, specimen handling, testing methods, result reporting, and notifying clinicians of critical results.
United States Diagnostics Market Size, Share, Trend and Forecast 2026 | TechS...TechSci Research
According to #TechSci Research report, United States Diagnostics Market stood at USD30.08billion in 2020 and is expected to grow at a steady rate of 5.17% during the forecast period.
Gain More Insight: https://bit.ly/3wWI0do
Get Sample Report: https://bit.ly/3ltFdo6
Website: https://www.techsciresearch.com/
Market Research News: https://techsciblog.com/
2. Country # open # open # open Trend
studies1 studies 2 studies
3
Brazil 581 637 737
Mexico 323 338 370
Argentina 253 271 281
Chile 163 157 173
Peru 158 150 144
Colombia 134 147 155
Info captured as open studies in clinicaltrials.gov on (1) 16 August 2010 and (2) 07 February 2011 and (3) 03 August 2011
3. Country # open # open # open Trend
studies 1 studies 2 studies 3
Venezuela 33 28 19
Panama 28 28 30
Costa Rica 28 17 14
Ecuador 16 16 13
Uruguay 7 9 8
Bolivia 5 5 7
Paraguay 3 4 4
Info captured as open studies in clinicaltrials.gov on (1) 16 August 2010 and (2) 07 February 2011 and (3) 03 August 2011
4. 0
100
200
300
400
500
700
800
600
01-ago-10
01-sep-10
01-oct-10
01-nov-10
01-dic-10
01-ene-11
01-feb-11
01-mar-11
01-abr-11
01-may-11
01-jun-11
Peru
Chile
Brazil
Mexico
Colombia
Argentina
5. Anywhere in the world as long as research
data is submitted to FDA.
12. Deficiency Code Inspections % of total
05- Failure to follow investigational plan 11/39 28.20%
06-Inadequate and inaccurate records 06/39 15,4%
03- Inadequate informed consent form 05/39 12,82%
04- Inadequate drug accountability 04/39 10,25%
16-Failure to report adverse drug 02/39 5,12%
reactions
02- Failure to obtain and/or document 01/39 2,56%
subject consent
http://www.accessdata.fda.gov/scripts/cder/cliil/
13. 14
12
10 Failure in reporting Adverse Drug
Reactions
8 Failure to Obtain and Document
Informed Consent
6
Inadequate Drug Accountability
4
Inadequate Informed Consent
2
0 Inadequate and Inprecise records
Failure in following Investigational
Plan
14. Selection of Study and Investigator (D4)
Studies that include vulnerable population.
Studies of Phase I-II Clinical Research.
Studies on investigational products of associated high risk.
Investigators that show a high recruitment rate in relation to other investigators
in the same study.
High or low SUSAR events in relation to other Investigators in the same study
Investigator is participating in a significant number of studies
Any relevant information received in safety reports or periodic reports that
justifies an Investigator Inspection according to ANMAT criteria.
Reports received by ANMAT related to inappropriate conduct by Investigator.
Other requirements also follow previous 690/2006 Provision by ANMAT
15. Inspection Communication (D7)
Inspections will be previously informed to Sponsor and/or
Principal Investigator with at least 15 calendar days previous to
the designated date, in order to guarantee availability of
research staff at the time of inspection.
If the inspection is prompted by safety reports, periodic
progress reports or a report due to inappropriate conduct by
Investigator, previous announcement of inspector visit may not
apply.
Other requirements also follow previous 690/2006 Provision by ANMAT
16. Initial Interview (D 8.2)
Inspections will show official identification, explain scope and
audit procedures.
During the Initial Interview Investigator study Staff and sponsor
representatives are allowed to be present.
Inspectors will request information who, what, when, where and
how about the delegation of functions to Investigator staff
related to several items including potential study participant
evaluation and selecting and randomizing study participants.
Inspectors may conduct interviews during the initiation to
Investigator study staff and if relevant to study participants.
Other requirements also follow previous 690/2006 Provision by ANMAT
17. Inspection Progress (D 8.3)
Inspectors may interview study participants and such interviews will be
documented in separate records from those of the Inspection
procedure. Such records will contain:
◦ Participant ID
◦ Interview objective or purpose
◦ Questions that are expected to be answered
◦ Answers received from study participants in the interview process
To be filed with ANMAT and will only be accessed by Investigator if the
request is justified and ANMAT expressly authorizes to do so.
If during the Inspection serious deviations to the regulation or serious
risk to study participants are identified, inspectors may decide to
interrupt study continuity.
Other requirements also follow previous 690/2006 Provision by ANMAT
18. Documentation Review (D 9)
Inspectors will review essential documents of investigator as per section C
of this regulation.
Review of Informed consent documentation will include
◦ If informed consent has been obtained from a legal representative of the study
participant, such power of representation will be documented with the clinical records.
◦ The informed consent process is documented in the clinical records of the participant
including:
date and time of process initiation,
clarification whether ample time was given to potential subject to reflect and ask questions,
which where the questions the potential subject asked,
that understanding of the information given was verified and
that two originals were signed and one given to the study participant.
◦ In the case of cultural, educational or economically vulnerable subject, informed consent
has been obtained in the presence of an independent witness who has also signed and
such process is documented in detail.
Other requirements also follow previous 690/2006 Provision by ANMAT
19. Documentation Review Continued (D 9)
If Inspectors identify major deviation in any study procedure,
such study procedure will be reviewed in a bigger sample of
subjects than the one originally planned.
Inspectors will verify gratuity of products and study
procedures and any protocol related payments to subjects by
proof of purchase or documented receipt or invoicing to
Investigator or sponsor in the case of study related tests or
exams.
Other requirements also follow previous 690/2006 Provision by ANMAT
20. Inspection on Site Records (D 10)
If Inspectors will write an inspection on site report detailing the
type of revision and scope of review done during the
inspection, as well as observations, findings and problems
identified.
If observations or issues remain to be answered or clarified, the
inspected party will have 10 working days to provide such
answers and clarifications.
Inspection on site records will be signed in three original parts
by investigator/sub-investigator, Inspectors and sponsor
representative; such originals will be distributed one for each
party accordingly.
Other requirements also follow previous 690/2006 Provision by ANMAT
21. Result Inspection Result (D10)
NAI No Action Indicated
No objections identified.
IAV Voluntary Action Indicated
Corrective actions on behalf of Investigator and/or sponsor are required, but no action if further needed on behalf of ANMAT
OAI Official Action Indicated
Further action is needed on behalf of ANMAT
Preventive actions may include: temporary suspension of recruitment, temporary suspension of study at inspected site,
restriction to investigator from conducting new studies.
Definite measures may include: definite suspension of recruitment of subjects, definite suspension of inspected study ,
definite suspension of all studies at inspected site, suspension of inspected study at all sites involved in the country, request
to sponsor to intensify study monitoring, request to sponsor to change investigator at site, request to sponsor to discard
study data generated at the site, notification to medical school where Investigator is affiliated, administrative or legal action
towards investigator and / or CRO and/ or sponsor.
Other requirements also follow previous 690/2006 Provision by ANMAT
23. 20
15 4
OAI
10 VAI
NAI
5 4 12
2 4 3
0
1995-1998 1999-2002 2003-2006 2007-2010
http://www.accessdata.fda.gov/scripts/cder/cliil/
24. 12
10
8
Failure to report to IRB
6
Inadequate Drug Accountability
4
Inadequate and Inprecise records
2
Failure in following Investigational
0 Plan
25. Deficiency Code Inspections % of total
05- Failure to follow investigational plan 9/28 32,14%
06-Inadequate and inaccurate records 05/28 17,85%
16-Failure to report adverse drug 03/28 10,71%
reactions
04- Inadequate drug accountability 01/28 3,57%
15- Failure to notify IRB of changes, 01/28 3,57%
failure to submit progress reports
http://www.accessdata.fda.gov/scripts/cder/cliil/
26. ANVISA may also, during the conduct of a clinical
investigation:
◦ request more information to those responsible for its execution
or monitoring, or
◦ conduct inspections to sites to verify the level of compliance to
Brazilian legislation and Good Clinical Practices (Americas
Document on Good Clinical Practices)
Agência Nacional de Vigilância Sanitária
www.anvisa.gov.br
RDC 39/08, Artigo 8º § 2°
27. Rutine Inspections -> notification in the
previous 15 days
For Cause Inspections -> no previous notification
Notification via fax or e-mail to Sponsor/CRO and
investigator.
INSTRUÇÃO NORMATIVA Nº 4, DE 11/05/09
28. •With presence •With presence
of PI + of PI + Sponsor
Sponsor/CRO
Inspection Inspection
Close Opening
Interview with
study staff + Inspection
Visit to the Opening
facilities
Max. 5 working days
INSTRUÇÃO NORMATIVA Nº 4, DE 11/05/09
29. After the inspection the Inspection preliminary report will be
sent to Sponsor/CRO and PI with finding classifications:
◦ Critical
◦ Major
◦ Minor
◦ Information
Sponsor/CRO will have 30 days to answer and an extension
request of 30 more days may be requested.
After considering Sponsor´s answers or past the due date,
ANVISA will send a final report stating whether or not study is
being conducted according to Good Clinical Practices.
INSTRUÇÃO NORMATIVA Nº 4, DE 11/05/09
30. Observations
Critical Observations directly related to the subjects safety that may
result in death, risk of death or unsafe conditions. In relation to
study data the van compromise the validity (unauthorized studies,
lack of data, falsification, forgery, etc. )
Major Observations that may put in risk the research subjects health or
affect validity of data.
Minor Observations not considered critical or major but that can reflect
a deficiency or deviation. They must be addressed for the
implementation of improvements in the conduct of clinical
studies.
Informative Descriptive or complementary observations
INSTRUÇÃO NORMATIVA Nº 4, DE 11/05/09
34. Training and Changes in Study Team
Recruitment and selection of research subjects
Procedure for obtaining Informed Consent
CRF Completion and correction of entered data
CRF and Source Data Verification
Utilization and calibration of equipments and Instruments
Administration, preparation and Transportation of IP
Receiving controlling and accounting of IP
Destruction and Return of Investigational Product (IP)
Power Failure contingency and IP Storage
Collection, transportation, preparation, Identification and analysis of lab
samples
Biologic and Non Biologic Materials
Unblinding of codes
AE and SAE notification
Organization and Maintenance of Files
37. Deficiency Code Inspections % of total
05- Failure to follow investigational plan 04/09 44,44%
06-Inadequate and inaccurate records 03/09 33,33%
04- Inadequate drug accountability 01/09 11,11%
15- Failure to notify IRB of changes, 01/09 11,11%
failure to submit progress reports
http://www.accessdata.fda.gov/scripts/cder/cliil/