BY: HARDIK BRAHMBHATTT

SHIVRATH COE IN CLINICAL RESEARCH

Difference Between Indian GCP and ICH

GCP

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Investigator Qualification

ICH – GCP: (4.1.1)The investigator(s) should be qualified by

education, training, experience to assume responsibility for the proper conduct of the trial, should meet all the qualifications specified by the applicable regulatory requirement(s)

Indian GCP: (3.3.1)The investigator should be qualified by

education, training and experience to assume responsibility for the proper conduct of the study and should have qualifications prescribed by the Medical Council of India (MCI).

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Investigator and sponsor’s SOPs

ICH – GCP: Investigator to comply with the protocol

(4.5) and leaves the task of monitoring compliance to SOPs to monitors and auditors (5.19.1).

Indian GCP: (3.1.3)The Sponsor should establish detailed

Standard Operating Procedures (SOP’s). The Sponsor and the Investigator(s) should sign a copy of the Protocol and the SOPs or an alternative document to confirm their agreement.

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Investigators responsibility for data analysis

ICH – GCP: (4.10)when the trial is completed, the investigator has

to provide the Independent Ethics Committee (IEC) with a summary of the outcome of trial.

Indian GCP: (3.3.8)The completion of the study should be informed

by the investigator to the institution, the sponsor and the ethics committee. The investigator should sign and forward the data (CRFs, results and interpretations, analyses and reports, of the study from his / her centre to the sponsor and the ethics committee.

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Essential Documents

ICH – GCP: (8.2)Investigator/ SponsorInstitution

Indian GCP: (APPENDIX V)Investigator / InstituteSponsorCROIEC

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Monitor Responsibilities

ICH – GCP: (5.18.4)Communicating deviations from the protocol,

SOPs, GCP, and the applicable regulatory requirements to the investigator and taking appropriate action designed to prevent recurrence of the detected deviations.

Indian GCP: (3.2.2)The monitor should promptly inform the sponsor

and the ethics committee in case any unwarranted deviation from the protocol or any transgression of the principles embodied in GCP is noted.

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Drug Label

Indian GCP: (2.3.1.6)In the section on protocol, it is mentioned that

drug label should include name and contact numbers of investigator and name of institution.

This is not a global practice. This will lead to practical difficulties in global

trials where the labels are uniform with minor changes made if required by local laws and practice.

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Document Retention

ICH – GCP: (5.18.4)Essential documents should be retained until at

least 2 years after the approval of a marketing application in an ICH region.

Indian GCP: (4.9)Indian GCP mandates that the sponsor should

make arrangements for safe and secure custody of all study related documents and material for a period of three years after the completion of the study or submission of the data to the regulatory authority (ies) whichever is later.