GCP stands for Good Clinical Practice. They are international standards, ethically and scientifically set for conducting, recording, formulating, documenting, and recording clinical trials that involve the participation of humans. These standards are measures to follow to ensure the safety and security of the public. The Indian GCP is somehow based on ICH GCP, though there are many key differences.
ICH GCP vs Indian GCP
The main 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.
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 has the responsibility to verify 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.
Comparison Table Between ICH GCP and Indian GCP
|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||Doesn’t need to be registered with MCI.||Have to be qualified and registered as per the MCI requirements.|
|Ethics committee members||Minimum 5 members should be there. The maximum number is not specified.||Minimum 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 and to speed up the marketing of new drugs and decreases 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 accuracy, completeness, timeliness of the data before submitting the report to the Sponsor and Ethics Committee. And the responsibility for legit verifying the documents which are provided by the investigator 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 simply 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, 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 responsibility of the investigator is to comply with the SOPs, analyze the data, make a study report on it, and submit it to the Sponsor as well as the Ethics Committee. Also, to forward the paperwork. And the responsibility of the monitor is to inform the ethics committee if there is any violation of the protocol.
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.
- In ICH GCP, there is no specified number about how many ethics committee members can be there. Although according to the Indian GCP, the maximum number of people in the ethics committee can be 12-15.
- There is no rule in ICH GCP that the drug label should contain the name and contact number of the investigator and the name of the institution as well. While the information has to be mentioned in 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.
The GCP is standard issued to ensure the rights, safety, and welfare of humans in clinical trials. The clinical trials have to be conducted as per these standards. Though the Indian GCP has been based a bit on the ICH GCP, there are some differences.
The ICH GCP insists that the monitor is responsible for verifying that the investigator forwarded documents are legit. The responsibility of the investigator and his team is to comply, sign the consent form, and provide the summary of the trial outcome to the EC.
According to the Indian GCP, the investigator has to sign the SOP as well as the Sponsors which makes the process a little tough than it is already is. Also, the investigator has to be qualified as per the requirements of MCI.