GCP stands for Good Clinical Practice. They are international standards, ethically and scientifically, set for conducting, recording, formulating, documenting, and recording clinical trials involving human participation.
These standards are measures to ensure the public’s safety and security. The Indian GCP is somehow based on ICH GCP, though there are many key differences.
ICH GCP vs Indian GCP
The difference between the ICH GCP and Indian GCP is that in ICH GCP, the investigator or the person designated by the investigator complies with SOP and leaves the monitoring compliance task of SOPs to the auditors and monitors. While in Indian GCP, the investigator and the sponsors should sign the SOP.
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According to the ICH GCP, the investigator has to conduct the consent process and sign the consent form. Also, he has to provide the outcome trial summary to the EC (Ethics committee).
And the monitor is responsible for verifying that the documents provided by the investigator are correct and legible.
The Indian GCP standard insists that the investigator should have qualifications according to the Medical Council of India(MCI). And it is the responsibility of the investigator to sign and forward the data to the ethics committee and the sponsors.
Also, the SOP has to be signed by both the investigator and the sponsor.
|Parameters of Comparison||ICH GCP||Indian GCP|
|Investigator responsibility||To submit a summary of the trial and its outcomes to the sponsors and EC.||To comply as well as sign SOPs, analyze the data, and make a study report on it.|
|SOP Sign||The administrator or the director signs the SOP.||Both investigator and the sponsor have to sign.|
|MCI||It doesn’t need to be registered with MCI.||Have to be qualified and registered as per the MCI requirements.|
|Ethics committee members||A minimum of 5 members should be there. The maximum number is not specified.||Minimum of 7 members and a maximum of 12 to 15 members are specified.|
|Record retention||Record retention time is 2 years.||Record retention is 3 years.|
What is ICH GCP?
ICH GCP stands for International Conference on Harmonization of Good Clinical Practice.
ICH GCP are standards to provide a uniform standard to ensure the safety and security of the public to investigational products, speed up the marketing of new drugs, and decrease the cost.
According to the ICH-GCP, the role of the investigator is to comply and leave the monitoring of SOPs to the monitor. Also, in data analysis, he has to submit a summary of the trial and its outcomes.
He has to ensure the data’s accuracy, completeness, and timeliness before submitting the report to the Sponsor and Ethics Committee. And the responsibility for legit verifying the documents which the investigator provides is of the monitor.
The period of record retention after the marketing authorization approval is 2 years. According to the ICH GCP, there is no specified number of the Ethics committee member, though there should be at least 5 members.
There are 13 core principles of ICH GCP that have to be followed, which protects the privacy and credibility of the documents as well as their accuracy and legibility. And the consent and confidentiality as well.
They also mention the qualification of the investigator and his research team.
What is Indian GCP?
Indian GCP is slightly based on the ICH GCP. Many of the standards are just modified a bit. The main objective is to streamline the clinical trials and ensure that the studies are scientifically authentic and that the documents are proper.
According to the Indian GCP, the investigator should have qualifications as per the requirements of the Medical Council of India.
Also, the SOP has to be signed by both the investigator and the sponsor, which makes the process a bit hard as the process of making revisions and handling several SOPs is already complex.
The investigator’s responsibility is to comply with the SOPs, analyze the data, make a study report on it, and submit it to the Sponsor and the Ethics Committee. Also, to forward the paperwork.
And the monitor’s responsibility is to inform the ethics committee if there is any protocol violation.
According to the Indian GCP, there should be at least 7 members in the ethics committee, and the maximum number of members should be 12 to 15. Also, it is a rule that there must be a woman on the committee.
Main Differences Between ICH GCP And Indian GCP
- In ICH GCP, the administrator or the director signs the SOP, while according to the Indian GCP, SOP has to be signed by both investigator and the sponsor.
- ICH GCP has no specified number about how many ethics committee members can be there. Although according to the Indian GCP, the maximum number of people on the ethics committee can be 12-15.
- There is no rule in ICH GCP that the drug label should contain the investigator’s name and contact number and the institution’s name as well. While the information has to be mentioned on the drug label according to the Indian GCP.
- There are no gender requirements in the EC Quorum, according to the ICH GCP. Though according to the Indian GCP, there should be at least one woman in the EC Quorum
- In ICH GCP, the qualification of the investigator is confirmed via training and experience. On the other hand, according to the Indian GCP, the investigator should qualify as per the MCI.
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Sandeep Bhandari holds a Bachelor of Engineering in Computers from Thapar University (2006). He has 20 years of experience in the technology field. He has a keen interest in various technical fields, including database systems, computer networks, and programming. You can read more about him on his bio page.