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gunturtheja

Details given by a sponsor to a contract research organisation to start a clinical trial?

I need all the data given by a sponsor to a contract research organisation to start a clinical trial. I also need details about the data which has to be collected during and after the clinical trial. Can anybody suggest me any (specific) websites where I can get all these details.

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A.V.R.

Favorite Answer

Depends on the nature of the trial.

1. Ethics committee clearance for such trials.

2. Results of invitro and invivo trials if applicable.

3. Hazard analysis.

4. Biocompatibility if applicable.

5. Informed consent form cleared by the ethics committee.

6. Indemnity bond.

etc..etc..

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