TSDP tells about the essential documents that are required for the #conduct of a clinical trial. For #regulatory medical writing training, contact hello@turacoz.in.
In any work or process documents that are needed before initiation, Between or generally the end of the process just like in a clinical trial those “Documents which permit evaluation of the conduct of a trial and the quality of the data produced. It is given in the 8th section of the ICH-GCP.
TSDP tells about the essential documents that are required for the #conduct of a clinical trial. For #regulatory medical writing training, contact hello@turacoz.in.
In any work or process documents that are needed before initiation, Between or generally the end of the process just like in a clinical trial those “Documents which permit evaluation of the conduct of a trial and the quality of the data produced. It is given in the 8th section of the ICH-GCP.
Table of contents
-Definition of CRF
-What is CRF
-Types & Methods of filling of CRF
-CRF Input team
-CRF Approval team
-Review team
-Facts about CRF
-Purpose of CRF
-CRF Development process & Guidelines
-Elements of CRF
-CRF Design
-CRF completion checklist
-CRF Design tools
-CRF use
-GCP connection
“CSR is a detailed regulatory document which gives the information about the methods and results (related to efficacy and safety) of a clinical trial. CSRs are created as a part of the process of submitting applications to the Regulatory Authorities for new medical treatments and for its approval. CSRs can be full, abbreviated, synopsis, supplementary, observational etc as per the results and requirements”.
Roles and Responsibilities of sponsor in conducting clinical trials as per GC...Dr B Naga Raju
Presentation on Roles and Responsibilities of sponsor in conducting clinical trials as per GCP-ICH for pursuing a subject in the course of PharmD programme under RGUHS
Roles and Responsibilities of sponsor, CRO, and investigator MOHAMMEDSALEEMJM
This slide mainly includes Roles and responsibilities of sponsor CRO and Investigator in Ethical conduct of Clinical Research as per ICH GCP Guidelines
Required mainly for Regulatory affairs students
SAE REPORTING TIMELINE AND COMPENSATION 2019Shweta Lal
This presentation is based on New Drug and Clinical Trial Rule 2019 which was published in 19 march 2019. I have described chapter VI ( compensation) and Seventh Schedule including SAE reporting timeline in India.
Essential Regulatory Documents in Clinical TrialsTrialJoin
The term ‘’essential documents’’ refers to the documents which, according to the ICH-GCP Guidelines, serve to evaluate the trial conducted, data quality and integrity. These documents are contained in the Trial Master File and are otherwise known as Regulatory Documents. Such documents are usually the important agreements, contracts, delegation logs, training logs, etc.
Maintaining and storing these essential regulatory documents is an important practice in clinical research. The proper filing and organization of these documents can greatly improve a clinical trial management. Usually, Regulatory Documents will be stored in a binder (or binders) that’s provided to the site for that specific study.
Filling out these documents and filing them properly is the site’s and especially the PI’s responsibility. Storing them properly is also the site’s responsibility, not the CRA’s. In any case, after the study is over, the sponsor or the CRO will inform the site if they should keep the originals or make copies of the Regulatory Documents for storage. Similarly, the sponsor or the CRO will also tell the site how long they need the documents to be kept and stored on-site.
When Digital Meets Medical: The Next Generation Clinical TrialCeline Pering
Proteus Digital Health is pioneering a new product paradigm at the intersection of the medical and consumer worlds. We make regulated medical products that are used by regular people in everyday life, so they need to behave more like consumer products. User research, to refine medical products, is done using highly controlled clinical trials, while great consumer products are generally created using very different design research methodologies. Attendees will learn how cross-pollination of the clinical research with the best of consumer research opens up a whole new discipline ripe for exploration.
Table of contents
-Definition of CRF
-What is CRF
-Types & Methods of filling of CRF
-CRF Input team
-CRF Approval team
-Review team
-Facts about CRF
-Purpose of CRF
-CRF Development process & Guidelines
-Elements of CRF
-CRF Design
-CRF completion checklist
-CRF Design tools
-CRF use
-GCP connection
“CSR is a detailed regulatory document which gives the information about the methods and results (related to efficacy and safety) of a clinical trial. CSRs are created as a part of the process of submitting applications to the Regulatory Authorities for new medical treatments and for its approval. CSRs can be full, abbreviated, synopsis, supplementary, observational etc as per the results and requirements”.
Roles and Responsibilities of sponsor in conducting clinical trials as per GC...Dr B Naga Raju
Presentation on Roles and Responsibilities of sponsor in conducting clinical trials as per GCP-ICH for pursuing a subject in the course of PharmD programme under RGUHS
Roles and Responsibilities of sponsor, CRO, and investigator MOHAMMEDSALEEMJM
This slide mainly includes Roles and responsibilities of sponsor CRO and Investigator in Ethical conduct of Clinical Research as per ICH GCP Guidelines
Required mainly for Regulatory affairs students
SAE REPORTING TIMELINE AND COMPENSATION 2019Shweta Lal
This presentation is based on New Drug and Clinical Trial Rule 2019 which was published in 19 march 2019. I have described chapter VI ( compensation) and Seventh Schedule including SAE reporting timeline in India.
Essential Regulatory Documents in Clinical TrialsTrialJoin
The term ‘’essential documents’’ refers to the documents which, according to the ICH-GCP Guidelines, serve to evaluate the trial conducted, data quality and integrity. These documents are contained in the Trial Master File and are otherwise known as Regulatory Documents. Such documents are usually the important agreements, contracts, delegation logs, training logs, etc.
Maintaining and storing these essential regulatory documents is an important practice in clinical research. The proper filing and organization of these documents can greatly improve a clinical trial management. Usually, Regulatory Documents will be stored in a binder (or binders) that’s provided to the site for that specific study.
Filling out these documents and filing them properly is the site’s and especially the PI’s responsibility. Storing them properly is also the site’s responsibility, not the CRA’s. In any case, after the study is over, the sponsor or the CRO will inform the site if they should keep the originals or make copies of the Regulatory Documents for storage. Similarly, the sponsor or the CRO will also tell the site how long they need the documents to be kept and stored on-site.
When Digital Meets Medical: The Next Generation Clinical TrialCeline Pering
Proteus Digital Health is pioneering a new product paradigm at the intersection of the medical and consumer worlds. We make regulated medical products that are used by regular people in everyday life, so they need to behave more like consumer products. User research, to refine medical products, is done using highly controlled clinical trials, while great consumer products are generally created using very different design research methodologies. Attendees will learn how cross-pollination of the clinical research with the best of consumer research opens up a whole new discipline ripe for exploration.
FDA 2013 Clinical Investigator Training Course: Issues in Clinical Trials Des...MedicReS
FDA 2013 Clinical Investigator Training Course: Issues in Clinical Trials Designs for Devices
Owen Faris, Ph.D.,Deputy Director, Division of Cardiovascular Devices, Office of Device Evaluation, CDRH, FDA
Presented at the Zurich Frontend Conference (http://2014.frontendconf.ch/) on August 29th, 2014. Here I presented ideas on the integration of user experience in the growing trends of Internet of Things (IoT) devices and wearable sensors.
Oncology Immunotherapy - Nivolumab and other PD-1/PD-L1 Targeted Agents (061213)Will Roettger
This is a short briefing on the oncology immunotherapy PD-1/PD-L1 targeted agents currently under development. In this briefing we look at the competitive landscape, PD-1/PD-L1 product profiles, positioning, strategy, as well as a development timeline and SWOT on the BMS PD-1 blocker nivolumab. Updates to this briefing will come as newer information is discovered.
Common Mistakes in the Medical Device Development ContinuumNAMSA
Getting a medical device to market is a long process made up of multiple stages. Each stage requires a number of elements that need to be considered before progress can be made with the device. And even after market approval has been obtained, there is a continuous need to reevaluate and test the device to maintain safety and efficacy.
Throughout this development process, several steps can be missed that may result in submission refusal, or possibly a faulty device.
UX Antwerp Meetup, 27th of September 2016 - Carolien Creemers, Functional Analyst et Nobel Biocare
"UX design for better patient care"
When developing medical device software, UX design is more than facilitating a positive user experience. It is also about preventing your design decisions from leading to any patient harm. In this talk, Carolien will outline the challenges and risks that arise when designing software for daily clinical use.
She will give you some practical insights on how the team at Nobel Biocare developed a UX process in line with ISO and FDA regulations that delivers software which is not only easy to use but also safe to use.
FDA Design Controls: What Medical Device Makers Need to KnowGreenlight Guru
FDA Design Control regulations defined in 21 CFR 820.30 have been in place for 20 years now, yet year after year they continue to be one of the top issues cited during inspections.
This does not, and should not, be the case for your medical device company.
Join us for this free, two-part webinar series presented by two of the world's leading experts on the topic to learn how to implement a design control process that will not only ensure compliance but will actually benefit your product development efforts.
(You can view both webinars here: http://www.greenlight.guru/webinar/medical-device-design-controls)
In Part 1, you'll learn about Intended Use, User Needs, Design Inputs, Design Reviews, Design History File (DHF) and Risk Management.
Specifically:
-The importance of getting your intended use right up front
-The difference between a user need and a design input that's verifiable
-What stakeholders need to be involved in the process and why
-When and how many design reviews you should hold
-Why FMEA alone is NOT risk management and how to integrate risk into the design and development process
In Part 2, you'll learn about Design Outputs, Device Master Record (DMR), Design Verification and Validation (V&V), Design Transfer and Regulatory Submissions.
Specifically:
-Why your design outputs need to be more than a drawing and their relationship to your DMR
-How usability and human factors fits into the overall product development
-Making sure you build the correct device and build it correctly with design V&V
-Common mistakes people make during design transfer to production and how to avoid them
-When you can and should make your regulatory submission
Easy UX Process Steps Must follow by every UX Designer Think 360 Studio
User experience (UX) and user interface (UI) designers are essential for any startup business. The ordinary generalization for ux designer is that they are regular graphic or visual designers. UX designers wear numerous caps in a startup. This includes showcasing, arranging, planning, imparting and testing. Every UX designer should follow these simple process.
When a new drug/device/surgical procedure/treatment or other potential medical innovation is developed it must be thoroughly tested to ensure that it is safe and does what it is supposed to be.
This presentation will provide a basic overview of clinical research process.
UX design (or user experience design) is becoming an increasingly important field for business owners around the world. Good UX design can make a website many times more profitable, while poor UX design can put a company out of business in the right situations. It's worth taking a look to determine if YOUR business could be furthered by some great user experience design.
This presentation is a brief overview of ICH-GCP guidelines. Although ICH-GCP is a very vast topic, still this presentation will cover almost all the points. The reader will be able to discuss about the roles and responsibilities of various personnel in clinical trials.
The presentation on ICHGCP guidelines overview.The presentation gives a detailed view of What is ICHGCP, Principles of ICH & GCP
IRB & IEC, Investigator, Sponsor, Clinical trial Protocol
Investigator brochures & Essential documents.
Guilty ‘Til Proven Innocent: A Look at IRB LiabilityMichael Swit
Presentation at ACRP Annual Meeting, focusing on how an IRB can face liability in particular scenarios in the clinical trial arena, including a discussion of best practices for IRBs.
What is a waiver of informed consent?
Waiver of Documentation of Informed Consent (45 CFR 46.117)
This means that the study team must provide a subject with the required consent information, but the study team is not required to obtain the subject's signature on the informed consent document.
What is a waiver in clinical trials?
A Protocol Waiver may be defined as the sponsor approval for a prospective protocol deviation. Such deviations can often involve (but may not be limited to) the active recruitment to a study of one or more participants who do not meet the inclusion/exclusion criteria as detailed in the study protocol.
What is the criteria for waiver of documentation of informed consent?
For research that is FDA-regulated, a waiver of documentation of consent may be granted only: When the research presents no more than minimal risk of harm to participants and involves no procedures for which written consent is normally required outside the research context.
What is the difference between a waiver and informed consent?
A waiver is legal document releasing or relinquishing a known right, claim, or privilege. In this context, it is the relinquishment to pursue a claim in a certain set of defined circumstances. Informed consent is a written acknowledgement that a participant understands the risks inherent in a particular activity.
Inform consent:- A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate
Inform consent Waiver:- It is a process in which informed consent is not obtained from subjects, or that eliminates or alters some (or all) of the elements of informed consent as set forth in Federal regulations (45 CFR 46.116d)
The IRB must ensure that the following 4 criteria are met prior to approving a waiver or alteration of consent:
The research poses no more than minimal risk to subjects
The research does not adversely affect the rights and welfare
The research not practicable without the waiver
Whenever appropriate. The subject will be provided with pertinent information after participation
Siro Clinical Research Institute. www.siroinstitute.com
Post Graduate Diploma in Clinical Research. Pharmacovigilance, Clinical Trials, Clinical Data Management, Clinical Operation, Medical writing.
#Pharmacovigilance #CDM #data #Clinicalresearch, #regulatoryaffairs, #medicalcoding, #clinicalSAS #management #health #comment #pune
#clinicalresearch #medicaldevices #career #opportunity #oncology
#safety #pharmajobs #gpat #pharmacy #mbbs #jobs #jobsearch #training #healthandsafety #nowhiring #healthcare #clinical #opportunities #doctor #medicine #hiring #bpharmajobs #coding #regulatoryaffairs #medical #nursing
#clinicalresearch #medicaldevices #career #opportunity #oncology #safety #pharmajobs #gpat #pharmacy #mbbs #jobs #jobsearch # #training #healthandsafety #nowhiring
A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having being informed of all aspects of the trial that are relevant to the subjects decision to participate.
Informed consent is documented by means of written, signed and dated informed consent form.
The goal of the informed consent process is to provide people with sufficient information so that they can make informed choices about whether to being or continue participation in clinical research.
Siro Clinical Research Institute
Siro Clinpharm initiative
www.siroinstitute.com
Post Graduate Diploma in Clinical Research. Pharmacovigilance, Clinical Trials, Clinical Data Management, Clinical Operation, Medical writing.
#Pharmacovigilance #CDM #data #Clinicalresearch, #regulatoryaffairs, #medicalcoding, #clinicalSAS #management #health #comment #pune
#clinicalresearch #medicaldevices #career #opportunity #oncology
#safety #pharmajobs #gpat #pharmacy #mbbs #jobs #jobsearch #training #healthandsafety #nowhiring #healthcare #clinical #opportunities #doctor #medicine #hiring #bpharmajobs #coding #regulatoryaffairs #medical #nursing
#clinicalresearch #medicaldevices #career #opportunity #oncology #safety #pharmajobs #gpat #pharmacy #mbbs #jobs #jobsearch # #training #healthandsafety #nowhiring #healthcare #clinical #opportunities #doctor #medicine #hiring #bpharmajobs #coding #regulatoryaffairs #medical #nursing #pharmacovigilance #statistics #biostatistician #opportunity #interview #biostatistics #statisticalprogramming #team #fresher #project #students #development #projects #work #leaders #people #learning #culture #productivity #leader #event #clinicalresearch #clinicaloperations #clinicaldatamanagement #cdm
#clinicalresearchassociate #clinicalresearchcoordinator #pharmacovigilance ,#medicalcoders ,#sas ,#SASprogrammers #Biosatisticians, #Clinicaltrialdesign, #eTMF #lifescience
#medicaldevices,#scdmindia,#societyforclinicaldata
#lifesciencemanagement,#pharmaceuticals,#medicalwriting
#clinicalresearchinstitute #CRA #CRC #Databasedesign
#pharmacovigilanceindia #CTA #pharmacist #EDC , #GCP #pharmacovigilance #clinicalresearch #quality #clinicalresearchassociate #clinicalresearchcoordinator #clinicalresearchjobs #clinicaltrialmanagement #clinicaltrials #clinicaltraining #pharmacy #pharmacylife #pharmacycollege #pharmaceutical #pharmacist #pharmaindustry
3. Study designStudy design
Design study doc.Design study doc.
Investigator
selection
Investigator
selection
Ethics committee
review
Ethics committee
review
Approval letterApproval letter
Statistical reviewStatistical review
Data ManagementData Management
Site initiationSite initiation
MonitoringMonitoring
Follow up visitFollow up visit
Final reportFinal report
Notification to
regulatory
authority
Notification to
regulatory
authority
End of trialEnd of trial
Patient enrollmentPatient enrollment
Investigator
meeting
Investigator
meeting
OVERVIEW OF CLINICAL TRIAL
8. • Principal communication link between the Sponsor
& Investigator
• Selection and qualification of Monitors
o Appointed by Sponsor
o Scientific & clinical knowledge to monitor the
trial
• Purpose: Securing compliance
• Extent & nature of monitoring: Determined by
Sponsor-on-site monitoring
• Procedures
• Monitors responsibilities
• Monitoring report
MONITORS
9. COMPOSITION:
• 8-12 members form IEC.
• Minimum 5 persons required to form the Quorum
BASIC LAYOUT:
1. Chairperson (from outside the Institution)
2. 1-2 clinicians from various Institute
3. 1-2 persons from basic medical sciences
4. 1 retired judge
5. 1 social scientist
6. 1 Philosopher/Ethicist/Theologist
7. 1 lay person
8. 1 member secretary
INDEPENDENT ETHICS COMMITTEE (IEC)
1. Safeguard the rights, safety and wellbeing of all
subjects
2. Obtain documents (as per ICH-GCP) and as per
schedule Y
3. Review clinical trial within reasonable time
4. Continuing review of each on-going trial atleast
once in a year
5. Review proposed research at convened meetings
1. Any unanticipated problems involving risks to
human subjects
2. Serious/continuous non-compliance with IRB
approval
3. Termination/suspension of IRB approval
10. INDEPENDENT ETHICS COMMITTEE (IEC)
• Risk to subjects minimized
• Risks to subjects reasonable w.r.t
anticipated benefits
• Subject selection equitable
• ICF to be taken from each subject(s)
or Subject’s LAR
• Adequate provision for monitoring
the data to ensure safety of subjects
• Adequate provision to protect privacy
of subjects and maintain
confidentiality of data
11. Subject Recruitment
Eligible Patients
Inclusion criteria Exclusion criteria
Eg: Age-18-65 yrs Eg: Age-below 18
yrs & above -65 yrs
Document Assent on
IRB approved assent
form
Assent verbally
obtained
Informal process
Children & ICF
Patient of 18 yrs give
Informed consent
STUDY SUBJECTS
16. Statement of specific principles on Research
using human participants in specific areas of
Biomedical Research
Statement of general principles on research
using human participants in Biomedical
Research.
REGULATORY AGENCY IN INDIA