1. In Informed Consent Process, As per ICH - GCP any one designated by the investigator to conduct and to sign the consent form. (Section 4.8.8) but in Indian GCP Investigator should sign the form. (Section 2.4.3.1).
2. In IEC section, Indian GCP recommended the maximum no. of IEC member (12-15) but ICH-GCP Maximum number is not detailed. In IEC section, Indian GCP recommended that Member Secretary belongs to the same Institution but ICH- GCP Not recommended.
3. As per Indian GCP Monitor is also responsible for ensuring that CRFs are legible. where ICH-GCP state that Monitor has to verify that the documents provided by the investigator are legible.
4. As per Indian GCP, Study related documents/materials should be safe guarded by the sponsor for 3 years. (Section 3.1.5) but in ICH-GCP the records are linked to marketing approval.
5. Investigator qualifications: The Indian GCP investigator should be qualified as per the requirement of the Medical Council of India (MCI).
6. Investigator and sponsor’s Sops: The Indian guideline mandates that the sponsor and the investigator should sign a copy of the Standard Operating Procedures (SOPs). Besides, the investigator and his staff have to be aware and comply with SOPs; ICH-GCP expects the investigator to comply with the protocol.
7. Investigators responsibility for data analysis: As per ICH-GCP, when the trial is completed, the investigator has to provide the Independent Ethics Committee (IEC) with a summary of the outcome of trial. In contrast, Indian GCP demands that 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 centre to the sponsor and the ethics committee.
8. Powers of IEC: According to Indian GCP (2.4.2.6), the 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. As per ICH-GCP, this is the responsibility of independent data-monitoring committee (IDMC).
9. EC Quorum: ICH GCP min of 5 members and Indian GCP min of 7 members.
10. EC Members: Indian GCP gender representation at least 1 women
2. In IEC section, Indian GCP recommended the maximum no. of IEC member (12-15) but ICH-GCP Maximum number is not detailed. In IEC section, Indian GCP recommended that Member Secretary belongs to the same Institution but ICH- GCP Not recommended.
3. As per Indian GCP Monitor is also responsible for ensuring that CRFs are legible. where ICH-GCP state that Monitor has to verify that the documents provided by the investigator are legible.
4. As per Indian GCP, Study related documents/materials should be safe guarded by the sponsor for 3 years. (Section 3.1.5) but in ICH-GCP the records are linked to marketing approval.
5. Investigator qualifications: The Indian GCP investigator should be qualified as per the requirement of the Medical Council of India (MCI).
6. Investigator and sponsor’s Sops: The Indian guideline mandates that the sponsor and the investigator should sign a copy of the Standard Operating Procedures (SOPs). Besides, the investigator and his staff have to be aware and comply with SOPs; ICH-GCP expects the investigator to comply with the protocol.
7. Investigators responsibility for data analysis: As per ICH-GCP, when the trial is completed, the investigator has to provide the Independent Ethics Committee (IEC) with a summary of the outcome of trial. In contrast, Indian GCP demands that 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 centre to the sponsor and the ethics committee.
8. Powers of IEC: According to Indian GCP (2.4.2.6), the 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. As per ICH-GCP, this is the responsibility of independent data-monitoring committee (IDMC).
9. EC Quorum: ICH GCP min of 5 members and Indian GCP min of 7 members.
10. EC Members: Indian GCP gender representation at least 1 women
good information.
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Dear Abhijeet, Thank you very much for sharing your view.
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ReplyDeleteCould you help me to know the Difference between ICH GCP, Indian GCP and Schedule - Y ?
Thank you
Schedule Y for India, is a kind of law and not a mere guideline. It is the requirement and guideline for permission and/or manufacture of drug entity for sale or to undertake any clinical trials in India. Its enforcement came into existence in 1988 was an essential provision for providing support to the upscale of generic pharma scenic present in those days. With the entry of large pharmaceutical companies along with the multiple multinationals in field of clinical research the needs changed and a revised version of Schedule Y in line with ICH-GCP standard was put forth in 1995.
ReplyDeleteWhereas ICH GCP is all about the conduct of Clinical Trials “A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected”.
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