Good Clinical Practices   (GCP) DR. RANJEET PRASAD (MPH,MBA,CCRP,BDS)
Agenda <ul><li>Evolution of GCP. </li></ul><ul><li>ICH-GCP. </li></ul><ul><li>Differences and Similarities between ICH-GCP...
Evolution <ul><li>Nuremberg Code, 1947 </li></ul><ul><li>Declaration of Helsinki, 1964  ->  2001 </li></ul><ul><li>ICH GCP...
ICH-GCP-Introduction <ul><li>Good Clinical Practices (GCP) is an international ethical & scientific quality standard for d...
ICH GCP- Objective <ul><li>To provide a unified standard for the EU, Japan & the US to facilitate the mutual acceptance of...
ICH GCP-Section 1 <ul><li>Section 1- Glossary of various terms, eg.. . </li></ul><ul><li>Adverse drug reaction & Adverse E...
ICH GCP-Section 1  Cont… <ul><li>Monitoring & Monitoring report </li></ul><ul><li>Protocol & Protocol Amendment </li></ul>...
ICH GCP-Section 2 <ul><li>Section 2- Principles of ICH-GCP . </li></ul><ul><li>2.1 Clinical Trials should be conducted in ...
<ul><li>2.3 The rights, safety, and well being of the trial subjects  are the most important considerations & should preva...
<ul><li>2.6  Trial should be conducted in compliance with the protocol that has received prior institutional review board ...
<ul><li>2.9 Freely given informed consent should be obtained from every subject prior to clinical trial participation </li...
<ul><li>2.12 Investigational products should be manufactured, handled and stored in accordance with applicable GMP, and us...
ICH-GCP-Section 3 Institutional Review Boards/ Independent Ethics Committee
Section 3.1: IRB/IEC Responsibilities <ul><li>Should safeguard the rights, safety & well being of all trial subjects. </li...
<ul><li>should conduct continuing review of each ongoing trial at intervals appropriate to the degree of risk to human sub...
Section 3.2: IRB/IEC Composition <ul><li>At least 5 members </li></ul><ul><li>At least one non scientific member </li></ul...
Section 3.3: Procedures <ul><li>The IRB/IEC should establish, document in writing, and follow its procedures, which should...
Section 3.4: Records <ul><li>The IRB/IEC should retain all relevant records (e.g., written procedures, membership lists, l...
ICH-GCP: Section 4 Investigator
Section 4.1 Investigator qualifications & Agreements <ul><li>Qualified (documented) by education, training & experience to...
Section 4.2: Adequate Resources <ul><li>Potential for recruitment </li></ul><ul><li>Sufficient time for trial conduct and ...
Section 4.3: Medical care of trial subjects <ul><li>Qualified physician investigator/sub investigator for the trial, shoul...
Section 4.4: Communication with IRB <ul><li>Written & dated approval for trial protocol, ICD, recruitment procedures etc p...
Section 4.5: Compliance with Protocol <ul><li>Should conduct trial in accordance with the protocol version agreed & docume...
Section 4.6: Investigational Product <ul><li>Responsible for accountability at site </li></ul><ul><li>May be assigned to p...
Section 4.7: Randomization Procedures and unblinding <ul><li>Should follow the trial’s randomization procedure </li></ul><...
Section 4.8: Informed Consent <ul><li>Comply with regulatory requirement, GCP and ethical principles </li></ul><ul><li>Doc...
<ul><li>Ample time for consent and opportunity for questions </li></ul><ul><li>Impartial witness for illiterate patients <...
Section 4.9 :Records and reports <ul><li>Should ensure accuracy, completeness, legibility and timeliness of data to sponso...
<ul><li>The investigator should submit written summaries of the trial status to the IRB/IEC annually, or more frequently, ...
Section 4.11:Safety Reporting <ul><li>SAE  should be reported immediately to sponsor, and timely as required to IRB/regula...
Section 4.12: Premature termination of trial <ul><li>If the trial is prematurely terminated or suspended for any </li></ul...
Section 4.13: Final Report <ul><li>Upon completion, should inform institution, IRB, and regulatory authorities with a summ...
ICH-GCP: Section 5 Sponsor Responsibilities
Sponsor <ul><li>An individual, company, institution, or organization which takes responsibility for the initiation, manage...
Section 5.1: Quality Assurance & Quality Control <ul><li>Implementing & maintaining QA and QC systems with written SOPs to...
Section 5.2: CRO <ul><li>A person or an organization (commercial, academic, or other) </li></ul><ul><li>contracted by the ...
Sponsor Responsibilities <ul><li>Designate  Medical Expertise :who will be readily available to advise on trial related me...
Sponsor Responsibilities Cont…. <ul><li>Information on investigational product  (Section 5.12) </li></ul><ul><li>Manufactu...
Monitoring <ul><li>The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded,...
Sponsor Responsibilities Cont…. <ul><li>Audit  (Section 5.19) </li></ul><ul><li>Noncompliance  (Section 5.20) </li></ul><u...
ICH-GCP: Section 6 <ul><li>CLINICAL TRIAL PROTOCOL  </li></ul><ul><li>AND  </li></ul><ul><li>PROTOCOL AMENDMENT(S)   </li>...
Protocol <ul><li>Document describing all aspects of the study </li></ul><ul><li>Well designed and thoroughly considered </...
Protocol- Relevant components <ul><li>General Information (Section 6.1) </li></ul><ul><li>Background Information  (Section...
Protocol- Relevant components Cont… <ul><li>Statistics (Section 6.9) </li></ul><ul><li>Direct Access to Source Data/Docume...
Sec 6.1: Protocol- General Information <ul><li>Protocol Title, identifying number & date. Amendment number </li></ul><ul><...
Sec. 6.2:Protocol- Objective & Justification <ul><li>Aims & objectives, phase of study </li></ul><ul><li>Name & descriptio...
Sec 6.4:  Protocol- Trial Design <ul><li>Primary & secondary endpoints </li></ul><ul><li>Randomized/comparator/blinded/ope...
Sec 6.4: Protocol- Trial Design Cont…. <ul><li>Proposed date of initiation of study </li></ul><ul><li>Discontinuation crit...
Sec 6.5:  Selection and Withdrawal of Subjects   <ul><li>Inclusion/ Exclusion criteria: </li></ul><ul><li>Specifications o...
Sec 6.7: Protocol-Assessment of Efficacy   <ul><li>Specifications of efficacy parameters </li></ul><ul><li>Descriptions of...
Sec 6.9: Protocol- Statistics <ul><li>Description of statistical methods employed </li></ul><ul><li>Timing of interim anal...
Sec 6.10: Direct Access to Source Data/Documents   <ul><li>The sponsor should ensure that it is specified in the protocol ...
Sec 6.11: Protocol- QC & QA <ul><li>Steps & procedures for monitoring study </li></ul><ul><li>Instructions for protocol de...
Sec 6.12:Protocol- Ethical considerations <ul><li>Description of how patients/volunteers would be informed </li></ul>
Sec 6.13:  Protocol-Data Handling and Record Keeping   <ul><li>Procedures for handling & processing records of effects and...
Sec. 6.14: Protocol- Finance & insurance <ul><li>Budget, financial aspects </li></ul><ul><li>Sources of economic support <...
ICH-GCP: Section 7 Informed Consent
Section 7: Investigator Brochure-Introduction  <ul><li>Compilation of the clinical and nonclinical data on the investigati...
Sec 7: Investigator Brochure: Contents <ul><li>Introduction </li></ul><ul><ul><li>Definition </li></ul></ul><ul><ul><li>Pu...
ICH-GCP: Section 8 <ul><li>ESSENTIAL DOCUMENTS FOR THE CONDUCT OF A CLINICAL TRIAL   </li></ul>
Sec 8: Essential Documents -Introduction <ul><li>Essential Documents are those documents which individually and collective...
Essential Documents to be Kept before Trial Commences <ul><ul><ul><li>Investigators Brochure </li></ul></ul></ul><ul><ul><...
Essential Documents to be Kept before Trial Commences <ul><ul><ul><li>CV  of  investigator and sub-investigators evidencin...
Essential Documents to be Kept During the Trial <ul><ul><ul><li>Investigator’s brochure updates </li></ul></ul></ul><ul><u...
<ul><ul><li>Curriculum Vitae of new investigators and sub-investigators </li></ul></ul><ul><ul><li>Updates to normal value...
<ul><ul><li>Notification by the originating investigator to sponsor of serious adverse evens and related reports </li></ul...
Essential Documents to be Kept  After Completion or Termination of the Trial <ul><ul><li>Investigational product(s) accoun...
Differences and similarities between ICH-GCP and Indian GCP
Indian GCP  : Dec 2001 <ul><li>Expert Committee set up by Central Drugs Standard Control Organization (CDSCO) in consultat...
STRUCTURE <ul><li>Glossary </li></ul><ul><li>Principles </li></ul><ul><li>IRB/IEC </li></ul><ul><li>Investigator </li></ul...
GCP - A Shared Responsibility   Sponsor   Investigator   Regulatory Authority   Ethics Committee
Performance Skills Knowledge What to Why to Want to How to GCP  IMPLEMENTATION
Schedule Y  DRUGS AND COSMETICS (IIND AMENDMENT) RULES, 2005  NOTIFICATION the 20th January, 2005 <ul><li>Amendment to Dru...
Schedule Y   <ul><li>Regulation and guidelines for permission to import and / or manufacture of new drugs for sale or to u...
122-A : Application for permission to import new drug 122-B : Application for approval to manufacture new drug  122-D:  Pe...
List of Appendices For Schedule Y
Appendix X Contents Of The Proposed Protocol  For Conducting Clinical Trials Appendix IX Stability Testing Of New Drugs Ap...
INFORMED CONSENT PROCESS ICH GCP Indian GCP Schedule-Y <ul><li>Any one designated by the investigator to conduct and to si...
ESSENTIAL  ITEMS FOR INFORMED CONSENT   ICH GCP Indian GCP Schedule-Y <ul><li>Not Explained </li></ul><ul><li>cover issues...
ETHICS COMMITTEE COMPOSITION ICH GCP Indian GCP Schedule-Y <ul><li>At least 5 members.  </li></ul><ul><li>At least 1 membe...
DRUG LABEL  ICH GCP Indian GCP Schedule-Y <ul><li>Not Explained </li></ul><ul><li>Should include name and contact numbers ...
DOCUMENT RETENTION ICH GCP Indian GCP Schedule-Y <ul><li>The records are linked to marketing approval </li></ul><ul><li>St...
POWERS OF IEC ICH GCP Indian GCP Schedule-Y <ul><li>It is the responsibility of independent data-monitoring committee (IDM...
STANDARD OPERATING PROCEDURES ICH GCP Indian GCP Schedule-Y <ul><li>Expects the investigator to comply with the protocol a...
INVESTIGATOR’S QUALIFICATION ICH GCP Indian GCP Schedule-Y <ul><li>Not Recommended </li></ul><ul><li>Should be qualified a...
Key Players in Clinical Research and their checklists
Players in Clinical Research <ul><li>Investigators </li></ul><ul><li>Sponsors </li></ul><ul><li>Regulatory agency </li></u...
Investigator’s checklist - 1 <ul><li>Interest, expertise, time and facilities </li></ul><ul><li>Interaction with sponsor <...
Investigator’s checklist - 2 <ul><li>Implementation </li></ul><ul><ul><li>Organizing, briefing and supervising the team </...
Sponsor’s checklist - 1 <ul><li>Scientific, regulatory and ethical basis of the protocol, PIS and ICF </li></ul><ul><li>In...
Sponsor’s checklist - 2 <ul><li>Data management and analysis </li></ul><ul><li>Drafting of study report </li></ul><ul><li>...
Regulator’s checklist <ul><li>Periodic review of current regulations from scientific and ethical angles </li></ul><ul><li>...
Ethics Committee’s checklist - 1 <ul><li>Need for trial </li></ul><ul><li>Scientific aspects of protocol with ethical impl...
Ethics Committee’s checklist - 2 <ul><ul><li>Treatment </li></ul></ul><ul><ul><ul><li>Withdrawal of current treatment </li...
Ethics Committee’s checklist - 3 <ul><li>Ethical aspects of protocol </li></ul><ul><ul><li>Information and consent form </...
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ICH-GCP AND THEIR DIFFIRENCES TO INDIAN CLINICAL TRIAL GUIDELINES

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This presentation will provide the detail of ICH-GCP E6 and their differences to Indian GCP and Shedule Y.

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  • The violation of human rights in clinical research was revealed most vividly in the experiments done by Nazi doctors on the inmates of concentration camps during World War II. To avoid such incidents, the Nuremberg Code was adopted in 1947. Based on it, the World Medical Association adopted the Declaration of Helsinki in 1964. It has been amended five times since then, most recently in 2001 at Edinburgh. It now forms the basis of various GCP guidelines. Since 1980 the pharmaceutical industry felt the need to have uniform ethical and scientific standards for clinical trials across the countries. Therefore, it took the lead to form the International Conference on Harmonization (ICH) for this purpose. The ICH had representatives of regulatory agencies and pharmaceutical industry from the USA, EU and Japan. They also invited contributions from Canada, Australia, the Nordic countries and the WHO. Their efforts culminated in the formulation and adoption of ICH GCP guidelines in 1996. Soon after, in 2000, the Indian Council of Medical Research (ICMR) released Ethical Guidelines for Biomedical Research in Human Subjects. These were followed, in 2001, by GCP Guidelines for Clinical Trials of Pharmaceutical Products In India from the CDSCO. These are the standards that clinical research workers in India have to follow now. If the research is international, then they also need to follow the ICH guidelines.
  • Can make hyperlinks to these
  • Can make hyperlinks to these
  • Clinical research, especially the trials of drugs, devices and diagnostics, involve four players who need to know, understand and follow GCP. They are: Investigator sponsor regulatory agency ethics committee During today and tomorrow, various experts will unfold before you the nuances of the various aspects of GCP. Therefore, I shall present the checklists that these players need to keep handy as ready reminders. These can help avoid common pitfalls in clinical research that lead to deviations from GCP.
  • An investigator needs to ask himself: Am I interested in this research? Do I have the necessary expertise, time and facilities? Do I find the protocol scientifically and ethically sound? Is the patient information concise, complete and readable? Is the ICF properly written? Am I free to publish the results even if they are unfavorable to the sponsor? Can I defend the proposal to the ethics committee? Can I know the concerns of the committee in advance so that I can have a chance to resolve them with the sponsor beforehand? Am I willing to follow the conditions laid down by the ethics committee while approving my proposal?
  • How shall I organize, brief and supervise my team for this research? How shall I facilitate the practice of informed consent? How shall I ensure accurate transcription of data from the patient’s file to his CRF before signing it? What precautions shall I take to ensure that serious adverse events are recorded, reported and followed up properly and in time? How will I schedule effective interaction with the sponsor’s monitor? What is my institution’s policy about direct access to patient files? How will I reconcile it with the protocol requirements? Do I have the facilities to archive source documents? What is my institution’s policy? Am I willing to go through the final report draft, verify the accuracy of data and conclusions, and amend it if necessary before approval? Am I willing to prepare for an audit from the sponsor or an inspection from the regulatory agency?
  • A sponsor needs to consider: Can I justify the protocol, patient information and consent form to investigators on scientific, ethical and regulatory grounds? Does the investigator have necessary qualifications, training and experience, besides time and interest? Do I have necessary regulatory approval, and does the investigator have ethics committee approval? Am I willing to have the results published even if they are unfavorable? Have I ensured the quality of trial supplies? Have I arranged for proper initiation, monitoring and auditing of the trial?
  • What arrangements have I made for data management and analysis? Have I provided for the drafting of study report? Am I willing to prepare the investigator for a regulatory inspection? Am I willing to archive the source documents if the investigator is unable to do so?
  • Are the trials I am asking for really necessary? Do the current regulations need a review from scientific and ethical angles? Can I offer advance consultation to sponsors on acceptable efficacy and safety criteria, comparator product to be used, and relevance of the protocol to the proposed claim? Can I have open advisory panel meetings for reviewing applications and making decisions? How can I make inspections of investigational centers purposeful and instructive?
  • The ethics committee need to ponder: Is there a need for this study? Will it produce useful information? Is the number of subjects justified? Is the choice of healthy volunteers or patients appropriate? Are they vulnerable persons?
  • If current treatment to be withdrawn, is it justified? Will it pose any risk to the patients? Is placebo to be used for comparison? Is its use justified and safe? Are the doses and routes of administration justifiable? Is the nature and frequency of assessment appropriate? Is any invasive procedure to be done? What is its justification and what safety precautions have been proposed? If assessments involve drawing of blood, is the total volume justifiable and safe?
  • Is patient information concise, complete and understandable? Are risks and benefits adequately and properly explained? Is compensation or other payment appropriate and adequate? Is there an insurance cover for study-related injury? Is the nature of treatment after study explained? Does the study require regulatory approval? If yes, has it been obtained by the sponsor?
  • Transcript of "ICH-GCP AND THEIR DIFFIRENCES TO INDIAN CLINICAL TRIAL GUIDELINES"

    1. 1. Good Clinical Practices (GCP) DR. RANJEET PRASAD (MPH,MBA,CCRP,BDS)
    2. 2. Agenda <ul><li>Evolution of GCP. </li></ul><ul><li>ICH-GCP. </li></ul><ul><li>Differences and Similarities between ICH-GCP , Indian GCP and Schedule-Y </li></ul><ul><li>Key Players in Clinical Research and their checklists </li></ul>
    3. 3. Evolution <ul><li>Nuremberg Code, 1947 </li></ul><ul><li>Declaration of Helsinki, 1964 -> 2001 </li></ul><ul><li>ICH GCP guidelines, 1996 </li></ul><ul><li>Ethical Guidelines for Biomedical Research in Human Subjects (ICMR), 2000 </li></ul><ul><li>GCP Guidelines, CDSCO, New Delhi, 2001 </li></ul>
    4. 4. ICH-GCP-Introduction <ul><li>Good Clinical Practices (GCP) is an international ethical & scientific quality standard for designing, conducting, recording & reporting trials that involve the participation of human subjects. </li></ul><ul><li>Compliance with this standard provides public assurance that rights, safety & well being of trial subjects are protected, consistent with the principles that have their origin in the declaration of Helsinki, and that the clinical trial data are credible </li></ul>
    5. 5. ICH GCP- Objective <ul><li>To provide a unified standard for the EU, Japan & the US to facilitate the mutual acceptance of clinical data by regulatory authorities in these jurisdictions </li></ul><ul><li>Should be followed when generating data that are intended to be submitted to regulatory authorities (only then??) </li></ul>
    6. 6. ICH GCP-Section 1 <ul><li>Section 1- Glossary of various terms, eg.. . </li></ul><ul><li>Adverse drug reaction & Adverse Event </li></ul><ul><li>Case report form & Clinical Study Report </li></ul><ul><li>Coordinating Committee & Contract Research Organization </li></ul><ul><li>Independent Ethics Committee & Institutional Review Board </li></ul><ul><li>Investigator & Investigator’s Brochure </li></ul>
    7. 7. ICH GCP-Section 1 Cont… <ul><li>Monitoring & Monitoring report </li></ul><ul><li>Protocol & Protocol Amendment </li></ul><ul><li>Serious Adverse Event </li></ul><ul><li>Source data & Source documents </li></ul><ul><li>Sponsor & Sponsor investigator </li></ul><ul><li>Standard Operating Procedures </li></ul><ul><li>Vulnerable subjects </li></ul>
    8. 8. ICH GCP-Section 2 <ul><li>Section 2- Principles of ICH-GCP . </li></ul><ul><li>2.1 Clinical Trials should be conducted in accordance with the ethical principles consistent with GCP and applicable regulatory requirements </li></ul><ul><li>2.2 Before a trial is initiated, forseeable risks & inconveniences should be weighed against anticipated benefit for the trial subject & society. </li></ul>
    9. 9. <ul><li>2.3 The rights, safety, and well being of the trial subjects are the most important considerations & should prevail over interests of science and society </li></ul><ul><li>2.4 The available nonclinical & clinical information on an investigational product should be adequate support the proposed clinical trial. </li></ul><ul><li>2.5 Clinical trials should be scientifically sound, and described in a clear, detailed protocol. </li></ul>ICH GCP-Section 2 Cont..
    10. 10. <ul><li>2.6 Trial should be conducted in compliance with the protocol that has received prior institutional review board (IRB)/ independent ethics committee (IEC) approval/favourable opinion. </li></ul><ul><li>2.7 The medical care and medical decisions for subjects should be the responsibility of a qualified physician </li></ul><ul><li>2.8 Each individual involved in conducting a trial should be qualified by education, training & experience to perform his respective task </li></ul>ICH GCP-Section 2 Cont..
    11. 11. <ul><li>2.9 Freely given informed consent should be obtained from every subject prior to clinical trial participation </li></ul><ul><li>2.10 All clinical information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification </li></ul><ul><li>2.11 The confidentiality of records that could identify patients should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirements </li></ul>ICH GCP-Section 2 Cont..
    12. 12. <ul><li>2.12 Investigational products should be manufactured, handled and stored in accordance with applicable GMP, and used in accordance with the protocol </li></ul><ul><li>2.13 Systems with procedures that assure the quality of every aspect of the trial should be implemented </li></ul>ICH GCP-Section 2 Cont..
    13. 13. ICH-GCP-Section 3 Institutional Review Boards/ Independent Ethics Committee
    14. 14. Section 3.1: IRB/IEC Responsibilities <ul><li>Should safeguard the rights, safety & well being of all trial subjects. </li></ul><ul><li>Should obtains following Documents: Protocol & their amendments, Patient Information sheet & consent form, subject recruitment procedures (e.g. advertisements), Investigator's Brochure (IB), available safety information, information about payments and compensation available to subjects, the investigator’s current curriculum vitae and/or other documentation evidencing qualifications, and any other documents that the IRB/IEC may need to fulfil its responsibilities </li></ul>
    15. 15. <ul><li>should conduct continuing review of each ongoing trial at intervals appropriate to the degree of risk to human subjects, but at least once per year. </li></ul><ul><li>Review Protocol/ ICD/ recruitment procedures/ IB/payments </li></ul><ul><li>Continuing review for Ongoing Progress/Adverse events </li></ul>Section 3.1: IRB/IEC Responsibilities Cont..
    16. 16. Section 3.2: IRB/IEC Composition <ul><li>At least 5 members </li></ul><ul><li>At least one non scientific member </li></ul><ul><li>At least one independent member </li></ul><ul><li>Maintain list of members and qualifications </li></ul><ul><li>Only independent members to vote </li></ul><ul><li>Quorum to be present </li></ul>
    17. 17. Section 3.3: Procedures <ul><li>The IRB/IEC should establish, document in writing, and follow its procedures, which should include </li></ul><ul><ul><li>Composition </li></ul></ul><ul><ul><li>Meeting Scheduling & conduct </li></ul></ul><ul><ul><li>Specify that trial starts only after IRB review </li></ul></ul><ul><ul><li>Specify regarding changes in protocol </li></ul></ul><ul><ul><li>Specify prompt reporting of adverse events </li></ul></ul>
    18. 18. Section 3.4: Records <ul><li>The IRB/IEC should retain all relevant records (e.g., written procedures, membership lists, lists of occupations/affiliations of members, submitted documents, minutes of meetings, and correspondence) for a period of at least 3 years after completion of the trial and make them available upon request from the regulatory authority(ies). </li></ul><ul><li>The IRB/IEC may be asked by investigators, sponsors or regulatory authorities to provide its written procedures and membership lists. </li></ul>
    19. 19. ICH-GCP: Section 4 Investigator
    20. 20. Section 4.1 Investigator qualifications & Agreements <ul><li>Qualified (documented) by education, training & experience to assume responsibility for proper trial conduct </li></ul><ul><li>Should be familiar with the appropriate use of the investigational product, IB, and other information provided by sponsor </li></ul><ul><li>Should be aware of, & should comply with, GCP and the applicable regulatory requirements </li></ul><ul><li>Should permit monitoring, auditing and inspection </li></ul><ul><li>Delegation of duties to appropriately qualified persons </li></ul>
    21. 21. Section 4.2: Adequate Resources <ul><li>Potential for recruitment </li></ul><ul><li>Sufficient time for trial conduct and completion </li></ul><ul><li>Staff, facilities </li></ul><ul><li>Ensure training to staff </li></ul>
    22. 22. Section 4.3: Medical care of trial subjects <ul><li>Qualified physician investigator/sub investigator for the trial, should be responsible for all trial related medical decisions </li></ul><ul><li>Adequate medical care during and after trail participation </li></ul><ul><li>Make reasonable efforts ascertaining for premature withdrawal from trial </li></ul>
    23. 23. Section 4.4: Communication with IRB <ul><li>Written & dated approval for trial protocol, ICD, recruitment procedures etc prior to trial initiation </li></ul><ul><li>Should provide latest copies of IB to IRB </li></ul><ul><li>Should provide all relevant documents for review during trial </li></ul>
    24. 24. Section 4.5: Compliance with Protocol <ul><li>Should conduct trial in accordance with the protocol version agreed & documented by the sponsor, IRB and regulatory authority </li></ul><ul><li>No changes allowed in the protocol except in case of immediate hazard to the patient; which should be submitted to all immediately </li></ul>
    25. 25. Section 4.6: Investigational Product <ul><li>Responsible for accountability at site </li></ul><ul><li>May be assigned to pharmacist/individual </li></ul><ul><li>Stored as specified by sponsor or regulatory authority </li></ul><ul><li>Used only in accordance with the protocol </li></ul>
    26. 26. Section 4.7: Randomization Procedures and unblinding <ul><li>Should follow the trial’s randomization procedure </li></ul><ul><li>Any premature unblinding to be explained to sponsor </li></ul>
    27. 27. Section 4.8: Informed Consent <ul><li>Comply with regulatory requirement, GCP and ethical principles </li></ul><ul><li>Documented Communication of revised ICD to IRB and patient </li></ul><ul><li>No influence or coercion to participate </li></ul><ul><li>Subject or their legal representative should be fully informed in their own language </li></ul><ul><li>Non technical language </li></ul>
    28. 28. <ul><li>Ample time for consent and opportunity for questions </li></ul><ul><li>Impartial witness for illiterate patients </li></ul><ul><li>Subject should receive a copy of the signed and dated ICD/ amendment </li></ul>Section 4.8: Informed Consent cont..
    29. 29. Section 4.9 :Records and reports <ul><li>Should ensure accuracy, completeness, legibility and timeliness of data to sponsor in CRF </li></ul><ul><li>Correction in CRF should be signed, dated </li></ul><ul><li>Maintain trial related documents </li></ul><ul><li>Financial agreements in place </li></ul><ul><li>Access to records by monitor, regulatory agency or auditors </li></ul><ul><li>Progress reports to IRB </li></ul>
    30. 30. <ul><li>The investigator should submit written summaries of the trial status to the IRB/IEC annually, or more frequently, if requested by the IRB/IEC. </li></ul><ul><li>The investigator should promptly provide written reports to the sponsor, the IRB/IEC (see 3.3.8) and, where applicable, the institution on any changes significantly affecting the conduct of the trial, and/or increasing the risk to subjects </li></ul>Section 4.10 :Progress reports
    31. 31. Section 4.11:Safety Reporting <ul><li>SAE should be reported immediately to sponsor, and timely as required to IRB/regulatory agency </li></ul><ul><li>Adverse events and/or laboratory abnormalities identified in the protocol as critical to safety evaluations should be reported to the sponsor according to the reporting requirements and within the time periods specified by the sponsor in the protocol. </li></ul><ul><li>For reported deaths, the investigator should supply the sponsor and the IRB/IEC with any additional requested information (e.g., autopsy reports and terminal medical reports). </li></ul>
    32. 32. Section 4.12: Premature termination of trial <ul><li>If the trial is prematurely terminated or suspended for any </li></ul><ul><li>reason , Investigator : </li></ul><ul><li>Should inform subjects </li></ul><ul><li>Should assure therapy and follow up </li></ul><ul><li>Should inform regulatory authorities </li></ul><ul><li>Should inform sponsor/IRB with explanation </li></ul>
    33. 33. Section 4.13: Final Report <ul><li>Upon completion, should inform institution, IRB, and regulatory authorities with a summary of the trial’s outcome </li></ul>
    34. 34. ICH-GCP: Section 5 Sponsor Responsibilities
    35. 35. Sponsor <ul><li>An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial </li></ul>
    36. 36. Section 5.1: Quality Assurance & Quality Control <ul><li>Implementing & maintaining QA and QC systems with written SOPs to ensure GCP compliance </li></ul><ul><li>Securing agreements from all sites for monitoring, auditing, and inspections </li></ul><ul><li>QC of data handling </li></ul><ul><li>Payment agreements </li></ul>
    37. 37. Section 5.2: CRO <ul><li>A person or an organization (commercial, academic, or other) </li></ul><ul><li>contracted by the sponsor to perform one or more of a sponsor’s </li></ul><ul><li>trial related duties and functions </li></ul><ul><li>Sponsor may transfer all or some duties to CRO </li></ul><ul><li>Ultimate responsibility for quality lies with the sponsor </li></ul><ul><li>Document of all duty delegation required </li></ul>
    38. 38. Sponsor Responsibilities <ul><li>Designate Medical Expertise :who will be readily available to advise on trial related medical questions or problems. (Section 5.3) </li></ul><ul><li>Trial design (Section.5.4), Trial management, Data handling and Record Keeping (Section 5.5) and Investigator selection (Section 5.6), Allocation of Responsibilities (Section 5.7) </li></ul><ul><li>Compensation to Subjects and Investigators (Section 5.8), Financing (Section 5.9) </li></ul><ul><li>Submission to regulatory authorities (Section 5.10) </li></ul><ul><li>Confirmation of review by IRBs (Section5.11) </li></ul>
    39. 39. Sponsor Responsibilities Cont…. <ul><li>Information on investigational product (Section 5.12) </li></ul><ul><li>Manufacturing, labeling, packaging & coding of product (Section 5.13) </li></ul><ul><li>Supplying and Handling Investigational Product(s) (Section 5.14) and Record Assess (Section 5.15) </li></ul><ul><li>Safety Evaluation (Section 5.16) and Adverse Drug Reaction Reporting (Section 5.17) </li></ul><ul><li>Monitoring (Section 5.18) </li></ul>
    40. 40. Monitoring <ul><li>The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, SOPs, GCP, and the applicable regulatory requirements </li></ul>
    41. 41. Sponsor Responsibilities Cont…. <ul><li>Audit (Section 5.19) </li></ul><ul><li>Noncompliance (Section 5.20) </li></ul><ul><li>Premature Termination or Suspension of a Trial (Section5.21) </li></ul><ul><li>Multicentre Trials (Section 5.22) </li></ul>
    42. 42. ICH-GCP: Section 6 <ul><li>CLINICAL TRIAL PROTOCOL </li></ul><ul><li>AND </li></ul><ul><li>PROTOCOL AMENDMENT(S) </li></ul>
    43. 43. Protocol <ul><li>Document describing all aspects of the study </li></ul><ul><li>Well designed and thoroughly considered </li></ul><ul><li>Well structured </li></ul><ul><li>Complete </li></ul>
    44. 44. Protocol- Relevant components <ul><li>General Information (Section 6.1) </li></ul><ul><li>Background Information (Section 6.2) </li></ul><ul><li>Trial Objectives and Purpose (Section 6.3) </li></ul><ul><li>Trial Design (Section 6.4) </li></ul><ul><li>Selection and Withdrawal of Subjects (Section 6.5) </li></ul><ul><li>Treatment of Subjects (Section 6.6) </li></ul><ul><li>Assessment of Efficacy (Section 6.7) </li></ul><ul><li>Assessment of safety (Section 6.8) </li></ul>
    45. 45. Protocol- Relevant components Cont… <ul><li>Statistics (Section 6.9) </li></ul><ul><li>Direct Access to Source Data/Documents (Section 6.10) </li></ul><ul><li>Quality Control and Quality Assurance (section 6.11) </li></ul><ul><li>Ethics (section 6.12) </li></ul><ul><li>Data handling & management (Section 6.13) </li></ul><ul><li>Financing and Insurance (Section 6.14) </li></ul><ul><li>Publication Policy (Section 6.15) </li></ul><ul><li>Supplements (Section 6.16) </li></ul>
    46. 46. Sec 6.1: Protocol- General Information <ul><li>Protocol Title, identifying number & date. Amendment number </li></ul><ul><li>Contact names, addresses </li></ul><ul><li>Name and title of Authorized signatory </li></ul><ul><li>Contact medical expert </li></ul><ul><li>Contact investigator(s) </li></ul><ul><li>Institution(s), Laboratories, department contact </li></ul>
    47. 47. Sec. 6.2:Protocol- Objective & Justification <ul><li>Aims & objectives, phase of study </li></ul><ul><li>Name & description of Inv product </li></ul><ul><li>Summary of non clinical & clinical studies </li></ul><ul><li>Summary of risks & benefits </li></ul><ul><li>Description of route of administration, dosage </li></ul><ul><li>Statement of GCP compliance </li></ul>
    48. 48. Sec 6.4: Protocol- Trial Design <ul><li>Primary & secondary endpoints </li></ul><ul><li>Randomized/comparator/blinded/open, placebo controlled </li></ul><ul><li>Blinding technique(double blind/single blind) </li></ul><ul><li>Randomization(method & procedure) </li></ul><ul><li>Diagram of design, procedure & stages </li></ul><ul><li>Medications permitted & not permitted during study </li></ul><ul><li>Description of study treatments, dose, route during study conduct </li></ul><ul><li>Packing/labeling description </li></ul><ul><li>Duration of subject participation & sequence of all study periods, including follow up </li></ul>
    49. 49. Sec 6.4: Protocol- Trial Design Cont…. <ul><li>Proposed date of initiation of study </li></ul><ul><li>Discontinuation criteria for subjects </li></ul><ul><li>Instructions on suspending or terminating the study </li></ul><ul><li>Procedures for monitoring compliance </li></ul>
    50. 50. Sec 6.5: Selection and Withdrawal of Subjects <ul><li>Inclusion/ Exclusion criteria: </li></ul><ul><li>Specifications of the subjects to be included (age, gender, ethnic groups, prognostic factors, diagnostic criteria) </li></ul><ul><li>Specify exclusion criteria </li></ul><ul><li>Subject withdrawal criteria & procedures </li></ul>
    51. 51. Sec 6.7: Protocol-Assessment of Efficacy <ul><li>Specifications of efficacy parameters </li></ul><ul><li>Descriptions of how these are measured and recorded </li></ul><ul><li>Time & periodicity of recording </li></ul><ul><li>Description of special analysis/ tests (PK, clinical, lab, radiology) </li></ul><ul><li>Specifications of safety parameters </li></ul><ul><li>Procedures for eliciting reports of and reporting ADR </li></ul><ul><li>Time &method of recording </li></ul><ul><li>Type, duration of follow up after adverse events) </li></ul>
    52. 52. Sec 6.9: Protocol- Statistics <ul><li>Description of statistical methods employed </li></ul><ul><li>Timing of interim analysis, if any </li></ul><ul><li>Details of enrollment plan </li></ul><ul><li>Significance level, power </li></ul><ul><li>Procedures for reporting any deviations from the original statistical plan </li></ul><ul><li>Selection of subjects to be included in final analysis </li></ul>
    53. 53. Sec 6.10: Direct Access to Source Data/Documents <ul><li>The sponsor should ensure that it is specified in the protocol or other written agreement that the investigator(s)/institution(s) will permit trial-related monitoring, audits, IRB/IEC review, and regulatory inspection(s), providing direct access to source data/documents </li></ul>
    54. 54. Sec 6.11: Protocol- QC & QA <ul><li>Steps & procedures for monitoring study </li></ul><ul><li>Instructions for protocol deviations </li></ul><ul><li>Allocation of duties & responsibilities within research teams </li></ul><ul><li>Quality control of methods & evaluation procedures </li></ul>
    55. 55. Sec 6.12:Protocol- Ethical considerations <ul><li>Description of how patients/volunteers would be informed </li></ul>
    56. 56. Sec 6.13: Protocol-Data Handling and Record Keeping <ul><li>Procedures for handling & processing records of effects and adverse events </li></ul><ul><li>Handling of Products: </li></ul><ul><ul><li>Safe handling and storage measures </li></ul></ul><ul><ul><li>System to be followed for labelling </li></ul></ul><ul><ul><li>Labeling specifications </li></ul></ul>
    57. 57. Sec. 6.14: Protocol- Finance & insurance <ul><li>Budget, financial aspects </li></ul><ul><li>Sources of economic support </li></ul><ul><li>Subject payments </li></ul><ul><li>Reimbursement to team members </li></ul><ul><li>Insurance details of study subjects </li></ul>
    58. 58. ICH-GCP: Section 7 Informed Consent
    59. 59. Section 7: Investigator Brochure-Introduction <ul><li>Compilation of the clinical and nonclinical data on the investigational product that are relevant to the study of the products in human subjects </li></ul>
    60. 60. Sec 7: Investigator Brochure: Contents <ul><li>Introduction </li></ul><ul><ul><li>Definition </li></ul></ul><ul><ul><li>Purpose </li></ul></ul><ul><ul><li>Information form </li></ul></ul><ul><ul><li>Edition </li></ul></ul><ul><ul><li>Type & extent </li></ul></ul><ul><ul><li>Review & revise </li></ul></ul><ul><ul><li>Up-date </li></ul></ul><ul><li>General consideration </li></ul><ul><li>Contents of the IB </li></ul><ul><li>Conclusion </li></ul>
    61. 61. ICH-GCP: Section 8 <ul><li>ESSENTIAL DOCUMENTS FOR THE CONDUCT OF A CLINICAL TRIAL </li></ul>
    62. 62. Sec 8: Essential Documents -Introduction <ul><li>Essential Documents are those documents which individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. </li></ul><ul><li>These documents serve to demonstrate the compliance of the investigator, sponsor and monitor with the standards of Good Clinical Practice and with all applicable regulatory requirements </li></ul>
    63. 63. Essential Documents to be Kept before Trial Commences <ul><ul><ul><li>Investigators Brochure </li></ul></ul></ul><ul><ul><ul><li>Signed protocols, amendments (if any) and sample CRF </li></ul></ul></ul><ul><ul><ul><li>Information given to the trial subjects </li></ul></ul></ul><ul><ul><ul><ul><li>Informed Consent </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Applicable translations of informed consent (if any) </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Any other written information </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Advertisements for subject recruitment </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Subject compensation </li></ul></ul></ul></ul><ul><ul><ul><li>Financial aspects of the trial </li></ul></ul></ul><ul><ul><ul><li>Compensation document for trial-related injury </li></ul></ul></ul><ul><ul><ul><li>Signed agreements of all involved parties </li></ul></ul></ul><ul><ul><ul><ul><li>Investigator and sponsor </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Investigator and CRO (if any) </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Investigator/institution and regulatory authorities (if any) </li></ul></ul></ul></ul><ul><ul><ul><li>Approval letter from the IRB </li></ul></ul></ul><ul><ul><ul><li>IRB Composition </li></ul></ul></ul><ul><ul><ul><li>Authorization or notification from the regulatory agencies (where required) </li></ul></ul></ul>
    64. 64. Essential Documents to be Kept before Trial Commences <ul><ul><ul><li>CV of investigator and sub-investigators evidencing qualifications </li></ul></ul></ul><ul><ul><ul><li>Normal values of labs /technical procedures included in the protocol </li></ul></ul></ul><ul><ul><ul><li>Medical/laboratory and technical procedures of tests </li></ul></ul></ul><ul><ul><ul><ul><li>Certification </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Accreditation </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Established Quality control (QC assessments) </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Other validations </li></ul></ul></ul></ul><ul><ul><ul><li>Sample labels attached to investigational product containers </li></ul></ul></ul><ul><ul><ul><ul><li>Instructions for handling investigational products and trial-related materials (sometimes this information is included in the investigator’s brochure) </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Shipping records of investigational products and trial-related materials </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Certificates of analysis of investigational products shipped </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Decoding procedures for blinded trials </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Master randomization list </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Pretrial monitoring report </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Trail initiation monitoring report </li></ul></ul></ul></ul>
    65. 65. Essential Documents to be Kept During the Trial <ul><ul><ul><li>Investigator’s brochure updates </li></ul></ul></ul><ul><ul><ul><li>Any revisions to: </li></ul></ul></ul><ul><ul><ul><ul><li>Protocol, amendments and CRF </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Informed consent form </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Written information provided to subjects/LAR </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Advertisement </li></ul></ul></ul></ul><ul><ul><ul><li>Dated, IRB approved documents of: </li></ul></ul></ul><ul><ul><ul><ul><li>Protocol amendments </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Revisions of informed consent, information to subjects/LAR </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Advertisements and any other documents given </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Continuing review of trial </li></ul></ul></ul></ul><ul><ul><ul><li>Dated Regulatory approved documents of: </li></ul></ul></ul><ul><ul><ul><ul><li>Authorizations and notifications </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Protocol amendments and other documents </li></ul></ul></ul></ul>
    66. 66. <ul><ul><li>Curriculum Vitae of new investigators and sub-investigators </li></ul></ul><ul><ul><li>Updates to normal value(s) range(s) for medical lab technical procedure(s), test(s) included in the protocol </li></ul></ul><ul><ul><li>Updates on medical/laboratory/technical procedure tests </li></ul></ul><ul><ul><ul><li>Certificates </li></ul></ul></ul><ul><ul><ul><li>Accreditation </li></ul></ul></ul><ul><ul><ul><li>Established quality control/external quality assessment </li></ul></ul></ul><ul><ul><ul><li>Other validations </li></ul></ul></ul><ul><ul><li>Documentation of investigational products and trial-related materials shipment </li></ul></ul><ul><ul><li>Certificate(s) of analysis for new batches of investigational products </li></ul></ul><ul><ul><li>Monitoring visit reports </li></ul></ul><ul><ul><li>Relevant communications other than site visits (Letters, meeting notes and notes of telephone calls) </li></ul></ul><ul><ul><li>Signed informed consent forms </li></ul></ul><ul><ul><li>Source documents </li></ul></ul><ul><ul><li>Signed, dated and completed CRF </li></ul></ul><ul><ul><li>Documentation of CRF Corrections </li></ul></ul>Essential Documents to be Kept During the Trial
    67. 67. <ul><ul><li>Notification by the originating investigator to sponsor of serious adverse evens and related reports </li></ul></ul><ul><ul><li>Notification by investigator (if applicable) to regulatory authorities and IRB of unexpected serious adverse reactions and of other safety information </li></ul></ul><ul><ul><li>Notification by sponsor to investigators of safety information </li></ul></ul><ul><ul><li>Subject screening log </li></ul></ul><ul><ul><li>Subject identification code list </li></ul></ul><ul><ul><li>Subject enrolling log </li></ul></ul><ul><ul><li>Investigational product(s) accountability at the sire </li></ul></ul><ul><ul><li>Signature sheet </li></ul></ul><ul><ul><li>Record of retained body fluids/tissue samples (if any) </li></ul></ul>Essential Documents to be Kept During the Trial
    68. 68. Essential Documents to be Kept After Completion or Termination of the Trial <ul><ul><li>Investigational product(s) accountability at sire </li></ul></ul><ul><ul><li>Documentation of investigational product(s) destruction </li></ul></ul><ul><ul><li>Completed subject identification code list ( to permit identification of all subjects enrolled in the trial in case of follow up is required – this information should be kept in a confidential manner and for agreed period of time ) </li></ul></ul><ul><ul><li>Audit certificate (if required) </li></ul></ul><ul><ul><li>Final trial close-out monitoring report </li></ul></ul><ul><ul><li>Treatment allocation and decoding documentation returned to sponsor to document any decoding that may have occurred </li></ul></ul><ul><ul><li>Final report by investigator to IRB where required </li></ul></ul><ul><ul><li>Final report by investigator to regulatory authorities where applicable to document completion of the trial </li></ul></ul><ul><ul><li>Clinical study report to document results and interpretation </li></ul></ul>
    69. 69. Differences and similarities between ICH-GCP and Indian GCP
    70. 70. Indian GCP : Dec 2001 <ul><li>Expert Committee set up by Central Drugs Standard Control Organization (CDSCO) in consultation with clinical expert has formulated this GCP guideline </li></ul><ul><li>Drug Technical Advisory Board (DTAB), the highest technical body under D&C, Act, has endorsed adoption of this GCP guideline for streamlining the clinical studies in India </li></ul><ul><li>These guidelines have been evolved with consideration of WHO, ICH, USFDA and European GCP guidelines as well as the Ethical Guidelines for Biomedical research on Human Subjects issued by the Indian Council of Medical Research. </li></ul>
    71. 71. STRUCTURE <ul><li>Glossary </li></ul><ul><li>Principles </li></ul><ul><li>IRB/IEC </li></ul><ul><li>Investigator </li></ul><ul><li>Sponsor </li></ul><ul><li>Protocol </li></ul><ul><li>Investigators’ Brochure </li></ul><ul><li>Essential Documents </li></ul><ul><li>Definitions </li></ul><ul><li>Pre-requisites </li></ul><ul><li>Responsibilities </li></ul><ul><li>Records & Data </li></ul><ul><li>Quality Assurance </li></ul><ul><li>Statistics </li></ul><ul><li>Special Concerns </li></ul><ul><li>Appendices </li></ul><ul><li>ICH E6 </li></ul><ul><li>Indian GCP </li></ul>
    72. 72. GCP - A Shared Responsibility Sponsor Investigator Regulatory Authority Ethics Committee
    73. 73. Performance Skills Knowledge What to Why to Want to How to GCP IMPLEMENTATION
    74. 74. Schedule Y DRUGS AND COSMETICS (IIND AMENDMENT) RULES, 2005 NOTIFICATION the 20th January, 2005 <ul><li>Amendment to Drugs and Cosmetics Act, 1940 </li></ul><ul><li>Enacted by Parliament in the Fifty-sixth year of Republic of India </li></ul><ul><li>Published in the Gazette of India Part-II, section 3, sub-section (i) vide G.S.R. 32(E), dated 20 th January, 2005 </li></ul>
    75. 75. Schedule Y <ul><li>Regulation and guidelines for permission to import and / or manufacture of new drugs for sale or to undertake clinical trials </li></ul><ul><li>It has outlined extensive study criteria in line with the globally accepted formats such as ICH and US FDA guidelines </li></ul><ul><li>REFER TO RULES 122A, 122B, 122D, 122DA, 122DAA and 122E </li></ul>
    76. 76. 122-A : Application for permission to import new drug 122-B : Application for approval to manufacture new drug 122-D: Permission to import or manufacture FDC 122-DA : Permission to conduct clinical trials for New Drug / Investigational New Drug 122-DAA : Clinical trial 122-E:New drug
    77. 77. List of Appendices For Schedule Y
    78. 78. Appendix X Contents Of The Proposed Protocol For Conducting Clinical Trials Appendix IX Stability Testing Of New Drugs Appendix VIII Ethics Committee Appendix VII Undertaking by the Investigator Appendix VI Fixed Dose Combinations (Fdcs) Appendix V Informed Consent Appendix IV Animal pharmacology Appendix III Animal toxicology (non-clinical toxicity studies) Appendix II Structure, contents & format for clinical study reports Appendix I-A Data required to be submitted by an applicant for grant of permission to import &/or manufacture a new drug already approved in the country. Appendix I Data to be submitted along with the application to conduct clinical trials / import / manufacture of new drugs for marketing in the country. Appendix XI Data Elements For Reporting Serious Adverse Events Occurring In A Clinical Trial . Appendix III Animal toxicology (non-clinical toxicity studies ) Appendix II Structure, contents & format for clinical study reports
    79. 79. INFORMED CONSENT PROCESS ICH GCP Indian GCP Schedule-Y <ul><li>Any one designated by the investigator to conduct and to sign the consent form.(4.8.8) </li></ul><ul><li>Investigator should sign the form. (2.4.3.1) </li></ul><ul><li>Investigator should sign the form.(Appendix V) </li></ul>
    80. 80. ESSENTIAL ITEMS FOR INFORMED CONSENT ICH GCP Indian GCP Schedule-Y <ul><li>Not Explained </li></ul><ul><li>cover issues of biological samples. (2.4.3.2) </li></ul><ul><li>Not Detailed </li></ul>
    81. 81. ETHICS COMMITTEE COMPOSITION ICH GCP Indian GCP Schedule-Y <ul><li>At least 5 members. </li></ul><ul><li>At least 1 member -nonscientific area. </li></ul><ul><li>Quorum members number not detailed. </li></ul><ul><li>Maximum number is not detailed. </li></ul><ul><li>Not recommended. </li></ul><ul><li>Fairly small (5-7 members). </li></ul><ul><li>Not Explained </li></ul><ul><li>The quorum should have a minimum of 5 members. </li></ul><ul><li>12 to 15 is the maximum recommended number. </li></ul><ul><li>Member Secretary belongs to the same Institution. </li></ul><ul><li>At least 7 members. </li></ul><ul><li>Not Explained. </li></ul><ul><li>The quorum should have at least 5 members. </li></ul><ul><li>Maximum number is not detailed. </li></ul><ul><li>Not recommended. </li></ul>
    82. 82. DRUG LABEL ICH GCP Indian GCP Schedule-Y <ul><li>Not Explained </li></ul><ul><li>Should include name and contact numbers of investigator and name of institution. (2.3.1.6) </li></ul><ul><li>Not Explained </li></ul>
    83. 83. DOCUMENT RETENTION ICH GCP Indian GCP Schedule-Y <ul><li>The records are linked to marketing approval </li></ul><ul><li>Study related documents/materials should be safe guarded by the sponsor for 3 years. (3.1.5) </li></ul><ul><li>Not Explained </li></ul>
    84. 84. POWERS OF IEC ICH GCP Indian GCP Schedule-Y <ul><li>It is the responsibility of independent data-monitoring committee (IDMC) </li></ul><ul><li>IEC has power to order discontinuation of a trial if goals of the trial have already been achieved or unequivocal results obtained. (2.4.2.6) </li></ul><ul><li>Not Explained </li></ul>
    85. 85. STANDARD OPERATING PROCEDURES ICH GCP Indian GCP Schedule-Y <ul><li>Expects the investigator to comply with the protocol and leaves the task of monitoring compliance to SOPs to monitors and auditors. </li></ul><ul><li>Mandates that the sponsor and the investigator should sign a copy of the Standard Operating Procedures (SOPs). (3.1.3) </li></ul><ul><li>Not Explained </li></ul>
    86. 86. INVESTIGATOR’S QUALIFICATION ICH GCP Indian GCP Schedule-Y <ul><li>Not Recommended </li></ul><ul><li>Should be qualified as per the requirement of the Medical Council of India (MCI). (3.3.1) </li></ul><ul><li>Not Explained </li></ul>
    87. 87. Key Players in Clinical Research and their checklists
    88. 88. Players in Clinical Research <ul><li>Investigators </li></ul><ul><li>Sponsors </li></ul><ul><li>Regulatory agency </li></ul><ul><li>Ethics Committee </li></ul>
    89. 89. Investigator’s checklist - 1 <ul><li>Interest, expertise, time and facilities </li></ul><ul><li>Interaction with sponsor </li></ul><ul><ul><li>Protocol, CRF, PIS and ICF </li></ul></ul><ul><ul><li>Financial grant </li></ul></ul><ul><ul><li>Publication policy </li></ul></ul><ul><li>Interaction with ethics committee </li></ul><ul><ul><li>Presentation and defense of protocol </li></ul></ul><ul><ul><li>Compliance with conditions of approval </li></ul></ul>
    90. 90. Investigator’s checklist - 2 <ul><li>Implementation </li></ul><ul><ul><li>Organizing, briefing and supervising the team </li></ul></ul><ul><ul><li>Facilitating informed consent process </li></ul></ul><ul><ul><li>Completing and signing CRFs </li></ul></ul><ul><ul><li>Reporting SAE </li></ul></ul><ul><ul><li>Interacting with monitor </li></ul></ul><ul><ul><li>Reviewing and approving final report </li></ul></ul><ul><ul><li>Archiving source documents </li></ul></ul><ul><ul><li>Preparing for audit and/or inspection </li></ul></ul>
    91. 91. Sponsor’s checklist - 1 <ul><li>Scientific, regulatory and ethical basis of the protocol, PIS and ICF </li></ul><ul><li>Investigator’s qualifications, training and experience </li></ul><ul><li>Regulatory and ethical approvals </li></ul><ul><li>Publication policy </li></ul><ul><li>Quality of trial supplies </li></ul><ul><li>Initiation, monitoring and audit </li></ul>
    92. 92. Sponsor’s checklist - 2 <ul><li>Data management and analysis </li></ul><ul><li>Drafting of study report </li></ul><ul><li>Preparation for inspection </li></ul><ul><li>Archives of source documents </li></ul>
    93. 93. Regulator’s checklist <ul><li>Periodic review of current regulations from scientific and ethical angles </li></ul><ul><li>Advance consultation to sponsors on protocols </li></ul><ul><ul><li>Efficacy and safety criteria </li></ul></ul><ul><ul><li>Comparator product </li></ul></ul><ul><li>Advisory panels for review of applications and decision making </li></ul><ul><li>Inspection of investigational centers </li></ul>
    94. 94. Ethics Committee’s checklist - 1 <ul><li>Need for trial </li></ul><ul><li>Scientific aspects of protocol with ethical implications </li></ul><ul><ul><li>Participants </li></ul></ul><ul><ul><ul><li>Number </li></ul></ul></ul><ul><ul><ul><li>Healthy volunteers or patients </li></ul></ul></ul><ul><ul><ul><li>Vulnerable persons </li></ul></ul></ul>
    95. 95. Ethics Committee’s checklist - 2 <ul><ul><li>Treatment </li></ul></ul><ul><ul><ul><li>Withdrawal of current treatment </li></ul></ul></ul><ul><ul><ul><li>Assignment of placebo </li></ul></ul></ul><ul><ul><ul><li>Dosage and route </li></ul></ul></ul><ul><ul><li>Assessment of response </li></ul></ul><ul><ul><ul><li>Nature and frequency </li></ul></ul></ul><ul><ul><ul><li>Invasive or non-invasive </li></ul></ul></ul><ul><ul><ul><li>Total blood drawn </li></ul></ul></ul>
    96. 96. Ethics Committee’s checklist - 3 <ul><li>Ethical aspects of protocol </li></ul><ul><ul><li>Information and consent form </li></ul></ul><ul><ul><ul><li>Content and language </li></ul></ul></ul><ul><ul><ul><li>Risks and benefits </li></ul></ul></ul><ul><ul><ul><li>Compensation or other payments </li></ul></ul></ul><ul><ul><ul><li>Insurance for study-related injury </li></ul></ul></ul><ul><ul><ul><li>Treatment after study </li></ul></ul></ul><ul><li>Regulatory approval </li></ul>
    97. 97. Happy Reading
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