ich gcp & indian clinical trial guideline

8/4/2019 ICH GCP & Indian Clinical Trial Guideline

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Good Clinical Practices(GCP)

Dr. Ranjeet Prasad

(MBA,CCRP,BDS)


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Agenda

Evolution of GCP.

ICH-GCP. Differences and Similarities between ICH-GCP , Indian

GCP and Schedule-Y

Key Players in Clinical Research and their checklists


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Evolution

Nuremberg Code, 1947

Declaration of Helsinki, 1964 2001

ICH GCP guidelines, 1996

Ethical Guidelines for Biomedical Research in Human

Subjects (ICMR), 2000

GCP Guidelines, CDSCO, New Delhi, 2001


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ICH-GCP-Introduction

Good Clinical Practices (GCP) is an international ethical &scientific quality standard for designing, conducting, recording& reporting trials that involve the participation of humansubjects.

Compliance with this standard provides public assurance thatrights, safety & well being of trial subjects are protected,

consistent with the principles that have their origin in thedeclaration of Helsinki, and that the clinical trial data arecredible


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ICH GCP- Objective

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

Should be followed when generating data that are intended to

be submitted to regulatory authorities (only then??)


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ICH GCP-Section 1

Section 1- Glossary of various terms, eg...

Adverse drug reaction & Adverse Event

Case report form & Clinical Study Report

Coordinating Committee & Contract Research Organization

Independent Ethics Committee & Institutional Review Board

Investigator & Investigators Brochure


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ICH GCP-Section 1 Cont

Monitoring & Monitoring report

Protocol & Protocol Amendment

Serious Adverse Event

Source data & Source documents

Sponsor & Sponsor investigator

Standard Operating Procedures

Vulnerable subjects


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ICH GCP-Section 2

Section 2- Principles of ICH-GCP.

2.1 Clinical Trials should be conducted in accordance with the

ethical principles consistent with GCP and applicable

regulatory requirements

2.2 Before a trial is initiated, forseeable risks & inconveniences

should be weighed against anticipated benefit for the trial

subject & society.


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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

2.4 The available nonclinical & clinical information on an

investigational product should be adequate support the

proposed clinical trial.

2.5Clinical trials should be scientifically sound, and described in

a clear, detailed protocol.

ICH GCP-Section 2 Cont..


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2.6 Trial should be conducted in compliance with the protocol thathas received prior institutional review board (IRB)/independent ethics committee (IEC) approval/favourableopinion.

2.7 The medical care and medical decisions for subjects shouldbe the responsibility of a qualified physician

2.8 Each individual involved in conducting a trial should bequalified by education, training & experience to perform hisrespective task



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2.9 Freely given informed consent should be obtained from

every subject prior to clinical trial participation

2.10 All clinical information should be recorded, handled, and

stored in a way that allows its accurate reporting,

interpretation and verification

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



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2.12 Investigational products should be manufactured, handled

and stored in accordance with applicable GMP, and used in

accordance with the protocol

2.13 Systems with procedures that assure the quality of every

aspect of the trial should be implemented



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ICH-GCP-Section 3

Institutional Review Boards/ Independent EthicsCommittee


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Section 3.1: IRB/IEC Responsibilities

Should safeguard the rights, safety & well being of all trialsubjects.

Should obtains following Documents: Protocol & theiramendments, Patient Information sheet & consent form,subject recruitment procedures (e.g. advertisements),Investigator's Brochure (IB), available safety information,information about payments and compensation available tosubjects, the investigators current curriculum vitae and/or

other documentation evidencing qualifications, and anyother documents that the IRB/IEC may need to fulfil itsresponsibilities


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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. Review Protocol/ ICD/ recruitment procedures/ IB/payments

Continuing review for Ongoing Progress/Adverse events

Section 3.1: IRB/IEC Responsibilities

Cont..


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Section 3.2: IRB/IEC Composition

At least 5 members

At least one non scientific member

At least one independent member

Maintain list of members and qualifications

Only independent members to vote

Quorum to be present


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Section 3.3: Procedures

The IRB/IEC should establish, document in writing, and

follow its procedures, which should include Composition

Meeting Scheduling & conduct

Specify that trial starts only after IRB review

Specify regarding changes in protocol

Specify prompt reporting of adverse events


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Section 3.4: Records

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, andcorrespondence) for a period of at least 3 years after

completion of the trial and make them available upon request

from the regulatory authority(ies).

The IRB/IEC may be asked by investigators, sponsors orregulatory authorities to provide its written procedures and

membership lists.


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ICH-GCP: Section 4

Investigator


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Section 4.1Investigator qualifications & Agreements

Qualified (documented) by education, training & experience to

assume responsibility for proper trial conduct

Should be familiar with the appropriate use of theinvestigational product, IB, and other information provided by

sponsor

Should be aware of, & should comply with, GCP and the

applicable regulatory requirements Should permit monitoring, auditing and inspection

Delegation of duties to appropriately qualified persons


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Section 4.2: Adequate Resources

Potential for recruitment

Sufficient time for trial conduct and completion

Staff, facilities

Ensure training to staff


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Section 4.3: Medical care of trial subjects

Qualified physician investigator/sub investigator for thetrial, should be responsible for all trial related medicaldecisions

Adequate medical care during and after trail participation

Make reasonable efforts ascertaining for prematurewithdrawal from trial


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Section 4.4: Communication with IRB

Written & dated approval for trial protocol, ICD,

recruitment procedures etc prior to trial initiation Should provide latest copies of IB to IRB

Should provide all relevant documents for review during

trial


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Section 4.5: Compliance with Protocol

Should conduct trial in accordance with the protocolversion agreed & documented by the sponsor, IRB and

regulatory authority No changes allowed in the protocol except in case of

immediate hazard to the patient; which should besubmitted to all immediately


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Section 4.6: Investigational Product

Responsible for accountability at site

May be assigned to pharmacist/individual

Stored as specified by sponsor or regulatory authority

Used only in accordance with the protocol


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Section 4.7: Randomization Procedures andunblinding

Should follow the trials randomization procedure

Any premature unblinding to be explained to sponsor


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Section 4.8: Informed Consent Comply with regulatory requirement, GCP and ethical

principles

Documented Communication of revised ICD to IRB and

patient

No influence or coercion to participate

Subject or their legal representative should be fully informed

in their own language

Non technical language


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Ample time for consent and opportunity for questions

Impartial witness for illiterate patients Subject should receive a copy of the signed and dated ICD/

amendment

Section 4.8: Informed Consentcont..


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Section 4.9 :Records and reports

Should ensure accuracy, completeness, legibility andtimeliness of data to sponsor in CRF

Correction in CRF should be signed, dated

Maintain trial related documents

Financial agreements in place

Access to records by monitor, regulatory agency or auditors

Progress reports to IRB


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The investigator should submit written summaries of the trial

status to the IRB/IEC annually, or more frequently, if

requested by the IRB/IEC. 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

Section 4.10 :Progress reports


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Section 4.11:Safety Reporting

SAE should be reported immediately to sponsor, andtimely as required to IRB/regulatory agency

Adverse events and/or laboratory abnormalities identified

in the protocol as critical to safety evaluations should bereported to the sponsor according to the reportingrequirements and within the time periods specified by thesponsor in the protocol.

For reported deaths, the investigator should supply thesponsor and the IRB/IEC with any additional requestedinformation (e.g., autopsy reports and terminal medicalreports).


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Section 4.12: Premature termination of trial

If the trial is prematurely terminated or suspended for any

reason , Investigator : Should inform subjects

Should assure therapy and follow up

Should inform regulatory authorities

Should inform sponsor/IRB with explanation


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Section 4.13: Final Report

Upon completion, should inform institution, IRB, and

regulatory authorities with a summary of the trials

outcome


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ICH-GCP: Section 5

Sponsor Responsibilities


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Sponsor

An individual, company, institution, or organizationwhich takes responsibility for the initiation,

management, and/or financing of a clinical trial


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Section 5.1: Quality Assurance & Quality Control

Implementing & maintaining QA and QC systems with written

SOPs to ensure GCP compliance

Securing agreements from all sites for monitoring, auditing,and inspections

QC of data handling

Payment agreements


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Section 5.2: CRO

A person or an organization (commercial, academic, or other)

contracted by the sponsor to perform one or more of a sponsors

trial related duties and functions

Sponsor may transfer all or some duties to CRO

Ultimate responsibility for quality lies with the sponsor

Document of all duty delegation required


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Designate Medical Expertise :who will be readily available to

advise on trial related medical questions or problems.(Section

5.3) Trial design (Section.5.4), Trial management, Data handling and

Record Keeping (Section 5.5) andInvestigator selection (Section5.6), Allocation of Responsibilities (Section 5.7)

Compensation to Subjects and Investigators (Section 5.8),

Financing (Section 5.9)

Submission to regulatory authorities (Section 5.10)

Confirmation of review by IRBs (Section5.11)


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Sponsor ResponsibilitiesCont.

Information on investigational product (Section 5.12)

Manufacturing, labeling, packaging & coding of product(Section 5.13)

Supplying and Handling Investigational Product(s) (Section

5.14) and Record Assess (Section 5.15)

Safety Evaluation (Section 5.16) and Adverse Drug ReactionReporting (Section 5.17)

Monitoring(Section 5.18)


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Monitoring

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 applicableregulatory requirements


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Cont.

Audit (Section 5.19)

Noncompliance (Section 5.20)

Premature Termination or Suspension of a Trial (Section5.21)

Multicentre Trials(Section 5.22)


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ICH-GCP: Section 6

CLINICAL TRIAL PROTOCOLAND

PROTOCOL AMENDMENT(S)


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Protocol

Document describing all aspects of the study

Well designed and thoroughly considered

Well structured Complete


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Protocol- Relevant components

General Information (Section 6.1)

Background Information (Section 6.2)

Trial Objectives and Purpose (Section 6.3)

Trial Design (Section 6.4)

Selection and Withdrawal of Subjects (Section 6.5)

Treatment of Subjects (Section 6.6)

Assessment of Efficacy (Section 6.7)

Assessment of safety (Section 6.8)


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Protocol- Relevant componentsCont

Statistics (Section 6.9)

Direct Access to Source Data/Documents (Section 6.10)

Quality Control and Quality Assurance (section 6.11)

Ethics (section 6.12)

Data handling & management (Section 6.13)

Financing and Insurance (Section 6.14)

Publication Policy (Section 6.15)

Supplements (Section 6.16)


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Sec 6.1: Protocol- General Information

Protocol Title, identifying number & date. Amendmentnumber

Contact names, addresses Name and title of Authorized signatory

Contact medical expert

Contact investigator(s)

Institution(s), Laboratories, department contact


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Sec. 6.2:Protocol- Objective & Justification

Aims & objectives, phase of study

Name & description of Inv product

Summary of non clinical & clinical studies Summary of risks & benefits

Description of route of administration, dosage

Statement of GCP compliance


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Sec 6.4: Protocol- Trial Design

Primary & secondary endpoints

Randomized/comparator/blinded/open, placebo controlled

Blinding technique(double blind/single blind) Randomization(method & procedure)

Diagram of design, procedure & stages

Medications permitted & not permitted during study

Description of study treatments, dose, route during study

conduct Packing/labeling description

Duration of subject participation & sequence of all studyperiods, including follow up


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Sec 6.4: Protocol- Trial DesignCont.

Proposed date of initiation of study

Discontinuation criteria for subjects

Instructions on suspending or terminating the study

Procedures for monitoring compliance


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Sec 6.5: Selection and Withdrawal of Subjects

Inclusion/ Exclusion criteria:

Specifications of the subjects to be included (age, gender,ethnic groups, prognostic factors, diagnostic criteria)

Specify exclusion criteria

Subject withdrawal criteria & procedures


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Sec 6.7: Protocol-Assessment of Efficacy Specifications of efficacy parameters

Descriptions of how these are measured and recorded

Time & periodicity of recording

Description of special analysis/ tests (PK, clinical, lab,radiology)

Specifications of safety parameters

Procedures for eliciting reports of and reporting ADR

Time &method of recording

Type, duration of follow up after adverse events)


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Sec 6.9: Protocol- Statistics

Description of statistical methods employed

Timing of interim analysis, if any

Details of enrollment plan

Significance level, power

Procedures for reporting any deviations from the original

statistical plan

Selection of subjects to be included in final analysis


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Sec 6.10: Direct Access to Source Data/Documents

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


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Sec 6.11: Protocol- QC & QA

Steps & procedures for monitoring study

Instructions for protocol deviations

Allocation of duties & responsibilities within research teams Quality control of methods & evaluation procedures


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Sec 6.12:Protocol- Ethical considerations

Description of how patients/volunteers would be informed


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Sec 6.13:

Protocol-Data Handling and Record Keeping Procedures for handling & processing records of

effects and adverse events

Handling of Products: Safe handling and storage measures

System to be followed for labelling

Labeling specifications


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Sec. 6.14: Protocol- Finance & insurance

Budget, financial aspects

Sources of economic support

Subject payments

Reimbursement to team members

Insurance details of study subjects


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ICH-GCP: Section 7

Informed Consent


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Section 7: Investigator Brochure-Introduction

Compilation of the clinical and nonclinical data on the

investigational product that are relevant to the study of theproducts in human subjects


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Sec 7: Investigator Brochure: Contents

Introduction

Definition

Purpose

Information formEdition

Type & extent

Review & revise

Up-date General consideration

Contents of the IB

Conclusion


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ICH-GCP: Section 8

ESSENTIAL DOCUMENTS FOR THE CONDUCT OF A

CLINICAL TRIAL


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Sec 8: Essential Documents -Introduction

Essential Documents are those documents which individually

and collectively permit evaluation of the conduct of a trial and

the quality of the data produced.

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


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Essential Documents to be Kept before TrialCommences

Investigators Brochure

Signed protocols, amendments (if any) and sample CRF

Information given to the trial subjects

Informed Consent

Applicable translations of informed consent (if any)

Any other written information

Advertisements for subject recruitment

Subject compensation

Financial aspects of the trial

Compensation document for trial-related injury

Signed agreements of all involved parties

Investigator and sponsor Investigator and CRO (if any)

Investigator/institution and regulatory authorities (if any)

Approval letter from the IRB

IRB Composition

Authorization or notification from the regulatory agencies (where required)


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Essential Documents to be Kept before Trial Commences

CV of investigator and sub-investigators evidencing qualifications

Normal values of labs /technical procedures included in the protocol

Medical/laboratory and technical procedures of tests

Certification Accreditation

Established Quality control (QC assessments)

Other validations

Sample labels attached to investigational product containers

Instructions for handling investigational products and trial-related materials(sometimes this information is included in the investigators brochure)

Shipping records of investigational products and trial-related materials Certificates of analysis of investigational products shipped

Decoding procedures for blinded trials

Master randomization list

Pretrial monitoring report

Trail initiation monitoring report


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Essential Documents to be Kept During the Trial

Investigators brochure updates

Any revisions to:

Protocol, amendments and CRF

Informed consent form

Written information provided to subjects/LAR

Advertisement

Dated, IRB approved documents of:

Protocol amendments

Revisions of informed consent, information to subjects/LAR

Advertisements and any other documents givenContinuing review of trial

Dated Regulatory approved documents of:

Authorizations and notifications

Protocol amendments and other documents


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Curriculum Vitae of new investigators and sub-investigators

Updates to normal value(s) range(s) for medical lab technical procedure(s), test(s)included in the protocol

Updates on medical/laboratory/technical procedure tests

Certificates Accreditation

Established quality control/external quality assessment

Other validations

Documentation of investigational products and trial-related materials shipment

Certificate(s) of analysis for new batches of investigational products

Monitoring visit reports

Relevant communications other than site visits (Letters, meeting notes and notes oftelephone calls)

Signed informed consent forms

Source documents

Signed, dated and completed CRF

Documentation of CRF Corrections



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Notification by the originating investigator to sponsor of serious adverse evens andrelated reports

Notification by investigator (if applicable) to regulatory authorities and IRB ofunexpected serious adverse reactions and of other safety information

Notification by sponsor to investigators of safety information

Subject screening log

Subject identification code list

Subject enrolling log

Investigational product(s) accountability at the sire

Signature sheet

Record of retained body fluids/tissue samples (if any)



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Essential Documents to be KeptAfter Completion or Termination of the Trial

Investigational product(s) accountability at sire

Documentation of investigational product(s) destruction

Completed subject identification code list (to permit identification ofall subjects enrolled in the trial in case of follow up is requiredthisinformation should be kept in a confidential manner and for agreedperiod of time)

Audit certificate (if required)

Final trial close-out monitoring report

Treatment allocation and decoding documentation returned tosponsor to document any decoding that may have occurred

Final report by investigator to IRB where required

Final report by investigator to regulatory authorities whereapplicable to document completion of the trial

Clinical study report to document results and interpretation


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Differences and similarities between ICH-GCP and

Indian GCP


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Expert Committee set up by Central Drugs Standard Control

Organization (CDSCO) in consultation with clinical expert has

formulated this GCP guideline

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

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.70

Indian GCP :Dec 2001


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STRUCTURE

Glossary

Principles IRB/IEC

Investigator

Sponsor

Protocol

Investigators Brochure

Essential Documents

Definitions

Pre-requisites Responsibilities

Records & Data

Quality Assurance

Statistics

Special Concerns

Appendices

ICH E6Indian GCP

71


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GCP - A Shared Responsibility

Sponsor

Investigator

Regulatory Authority

Ethics Committee

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Performance

SkillsKnowledge

Attitude

What to

Why to73

Want to

How to

GCP IMPLEMENTATION


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Amendment to Drugs and Cosmetics Act, 1940

Enacted by Parliament in the Fifty-sixth year of Republic of

India

Published in the Gazette of India Part-II, section 3, sub-section(i) vide G.S.R. 32(E), dated 20th January, 2005

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Schedule YDRUGS AND COSMETICS (IIND AMENDMENT)

RULES, 2005 NOTIFICATION the 20th January, 2005


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Regulation and guidelines for permission to import and / or

manufacture of new drugs for sale or to undertake clinical trials

It has outlined extensive study criteria in line with the globally

accepted formats such as ICH and US FDA guidelines

REFER TO RULES 122A, 122B, 122D, 122DA, 122DAA and122E

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Schedule Y


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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 drug76


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List of Appendices For Schedule Y


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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 InvestigatorAppendix VI

Fixed Dose Combinations (Fdcs)

Appendix V

Informed ConsentAppendix 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 anapplicant 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 applicationto 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.

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Appendix III

Animal toxicology (non-clinical toxicity studies)

Appendix II

Structure, contents & format for clinical

study reports


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INFORMED CONSENT PROCESS

ICH GCP Indian GCP Schedule-Y

Any one designatedby the investigator to

conduct and to sign

the consent

form.(4.8.8)

Investigator shouldsign the form. (2.4.3.1)

Investigatorshould sign the

form.(Appendix

V)


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Not Explained cover issues ofbiological samples.

(2.4.3.2)

Not Detailed

ESSENTIAL ITEMS FOR INFORMED CONSENT


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ETHICS COMMITTEE COMPOSITION


At least 5 members.

At least 1 member -nonscientific area.

Quorum members

number not detailed.

Maximum number is not

detailed.

Not recommended.

Fairly small (5-7 members).

Not Explained

The quorum should have a

minimum of 5 members.

12 to 15 is the maximum

recommended number.

Member Secretary belongs

to the same Institution.

At least 7 members.

Not Explained.

The quorum should

have at least 5

members.

Maximum number is

not detailed.

Not recommended.


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Not Explained Should include name

and contact numbers

of investigator and

name of institution.

(2.3.1.6)

Not Explained

DRUG LABEL


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DOCUMENT RETENTION


The records arelinked to marketing

approval

Study relateddocuments/materials

should be safe

guarded by the

sponsor for 3 years.

(3.1.5)

Not Explained


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POWERS OF IEC


It is the

responsibility ofindependent data-

monitoring

committee (IDMC)

IEC has power to

order discontinuationof a trial if goals of

the trial have already

been achieved or

unequivocal results

obtained. (2.4.2.6)

Not Explained


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STANDARD OPERATING PROCEDURES


Expects the

investigator tocomply with the

protocol and leaves

the task of

monitoring

compliance to

SOPs to monitors

and auditors.

Mandates that the

sponsor and theinvestigator should

sign a copy of the

Standard Operating

Procedures (SOPs).

(3.1.3)

Not Explained


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INVESTIGATORS QUALIFICATION


Not

Recommended

Should be qualified

as per the

requirement of the

Medical Council of

India (MCI). (3.3.1)

Not Explained


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Key Players in Clinical Research

and their checklists


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Players in Clinical Research

Investigators

Sponsors

Regulatory agency

Ethics Committee


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Investigators checklist - 1

Interest, expertise, time and facilities

Interaction with sponsor

Protocol, CRF, PIS and ICF Financial grant

Publication policy

Interaction with ethics committee

Presentation and defense of protocol Compliance with conditions of approval


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Investigators checklist - 2

Implementation

Organizing, briefing and supervising the team

Facilitating informed consent process

Completing and signing CRFs

Reporting SAE

Interacting with monitor

Reviewing and approving final report

Archiving source documents

Preparing for audit and/or inspection


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Sponsors checklist - 1

Scientific, regulatory and ethical basis of the protocol, PIS and

ICF

Investigators qualifications, training and experience Regulatory and ethical approvals

Publication policy

Quality of trial supplies

Initiation, monitoring and audit


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Sponsors checklist - 2

Data management and analysis

Drafting of study report Preparation for inspection

Archives of source documents


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Regulators checklist

Periodic review of current regulations from scientific andethical angles

Advance consultation to sponsors on protocols Efficacy and safety criteria

Comparator product

Advisory panels for review of applications and decision

making Inspection of investigational centers


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Ethics Committees checklist - 1

Need for trial

Scientific aspects of protocol with ethical implications Participants

Number

Healthy volunteers or patients

Vulnerable persons


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Treatment

Withdrawal of current treatment

Assignment of placebo

Dosage and route

Assessment of response

Nature and frequency Invasive or non-invasive

Total blood drawn


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Ethical aspects of protocol

Information and consent form

Content and language

Risks and benefits

Compensation or other payments

Insurance for study-related injury Treatment after study

Regulatory approval


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