Differences between Indian GCP and ICH-GCP by CR Tutor

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Indian-GCP ICH-GCP

Section 2.4.3.1: As per Indian GCP, The PI should sign

the Informed Consent Form.

Section 4.8.8: The ICH should be signed by In Informed

Consent Process, As per ICH - GCP any one designated

by the investigator to conduct and to sign the consent

form.

IEC Section: The maximum number of EC

members should be 12-15

ICH-GCP does not specify the number of IEC

members

IEC Section: It is recommended that the Member

Secretary should belong to the same institution

ICH-GCP has no such recommendation

Monitoring: Monitor is responsible to ensure that

CRFs are legible

Monitor is only responsible verify that the documents

provided by the investigator are legible.

Section: 3.1.5: Record Retention time is 3 years

after completion of the trial.

Record retention is 2 years after the marketing

authorization approval.

Investigator Qualifications: The Investigator

should be qualified as per Medical Council of

India(MCI)

The Investigator should be qualified by training

and experience

Investigator Responsibilities: It is mandated that the

Sponsor and the Investigator should sign a copy of the

Standard Operating Procedures (SOPs).

The investigator is expected to comply with the

protocol.

Investigator Responsibilities: Upon trial completion,

the Investigator should sign and forward the data like

Case Report Forms (CRF), results and interpretations,

analyses and reports of the study from his/her center

to the sponsor and the ethics committee

Upon trial completion, the investigator has to provide

the Independent Ethics Committee (IEC) with a

summary of the outcome of trial.

Section 2.4.2.6: IEC has power to order discontinuation

of a trial if the IEC finds that the goals of the trial have

already been achieved mid-way or unequivocal results

obtained

The responsibility lies with independent data-

monitoring committee (IDMC).

IEC Section: The EC Quorum should be a minimum of

7 members

The EC quorum should be a minimum of 5 members

IEC Section: The quorum should involve one woman

at least.

There is no requirement as such.