CDSCO GCP GUIDELINES PDF

The guidelines should be followed when data from clinical trials should be submitted to regulatory authorities. Some of the guidelines found in the Indian version result in the difficult methodology which becomes overwhelming for sponsors and investigators. SOPs from investigator and sponsors are at issue. The Indian guidelines state that the copy for the SOPs must be duly signed by both the investigator and the sponsor. The investigator, with his research team, should comply with the SOPs. This may be impossible since it will become a huge burden for sponsors to get the SOPs signed by all the investigators of the trial.

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The guidelines should be followed when data from clinical trials should be submitted to regulatory authorities. Some of the guidelines found in the Indian version result in the difficult methodology which becomes overwhelming for sponsors and investigators.

SOPs from investigator and sponsors are at issue. The Indian guidelines state that the copy for the SOPs must be duly signed by both the investigator and the sponsor. The investigator, with his research team, should comply with the SOPs. This may be impossible since it will become a huge burden for sponsors to get the SOPs signed by all the investigators of the trial.

The entire process of maintaining several SOPs and making revisions are complex enough. The role of the investigator in data analysis, according to the ICH-GCP, is to submit a recap of the trial and its outcomes to the Sponsor and its Ethics Committee, while the Indian GCP mentions that the investigator or the institution should analyze the data, make a study report, and submit it to the Sponsor and Ethics Committee.

This tends to double the workload of the busy investigators and Ethics Committee. In addition, this will result in various study reports for various sites of a similar study. The Indian GCP offers patients the freedom to choose not to make the samples collected for analysis available for possible future use; considering that there is a possibility that the samples can be shared at any time. This section may create a conflict in the Informed Consent Process and might discourage patients from enrolling in clinical trials.

According to the ICH-GCP, the monitor is the one who is responsible for verifying how legible the documents are which are provided by the investigator or the site. This may be impossible since the monitor does not have direct contact with the Ethics Committee. Lastly, after all the considerations are reviewed, it can be stated that the creation of the Indian GCP came to happen so that the good deeds will be anticipated, but it will be more applicable if the implications are made easy to comply with.

In Indian GCP, the retained body samples genetic material may not be reused for future trials when there is a need to repeat it. ICH-GCP states that the monitor should be the one to verify the legibility of documents, while Indian GCP states that the monitor also needs to inform the Sponsor and Ethics Committee for any violations from the protocol.

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