What is the difference between schedule y and gcp

However, there are some annexures which require specific details of the device. Annexure I form 44 covers particulars of subject device e. See Below. Schedule Y iv Any unexpected serious adverse event SAE as defined in GCP Guidelines occurring during a clinical trial should be communicated promptly within 14 calendar days by the sponsor to the licensing authority and to the other investigator s participating in the study.

Indian GCP 3. Safety Information: Sponsor is responsible for the ongoing safety evaluation of the product. The Sponsor, together with Investigator s , should take appropriate measures necessary to safeguard the study subjects. One can act as legal expert and other one act as lay person. Did you find this document useful? Is this content inappropriate?

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A few of the guidelines utilized at the Indian variant lead to the tricky methodology that becomes overwhelming for sponsors and investigators. The Indian principles state that the copy for the SOPs have to be signed by both the investigator and the sponsor.

The investigator, together with his research team, should comply with the SOPs. This could not be possible as it will grow to be a huge burden for patrons to get the SOPs signed with all the investigators of this trial.

The full procedure of keeping several SOPs and making alterations are complicated enough. The role of the investigator in data evaluation, as stated by the ICH-GCP, will be to submit a recap of this trial and its outcomes to the Sponsor and its Ethics Committee, although the Indian GCP mentions that the investigator or the institution ought to analyze the data, create a study report, and submit it to the Sponsor and Ethics Committee.