Recruitment and study contract

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Dear members and friends

As i discussed regarding funnel effect i.e. progressive shrinking of patient population on successive screenings. To avoid much dropouts and discontinuation rates additional sample must be taken to fulfill requirements. Additional participants should be recruited to avoid unnecessary delay in trial.

Now, we will move towards the topic recruitment and the study contract.

Recruitment and the Study Contract

Specific recruitment targets are often detailed in the protocol and by signing the anticipation agreement, a site agrees to meet these targets. The site should ensure that it can meet these goals before the contract is signed, as this is a legally signing document.

The site specific assessment should be done to make sure that site is able to contribute to the study. In some cases recruitment will be competitive; sites can enroll as many subjects as possible until the total sample size has been reached. Sometimes the sponsor will offer a bonus, e.g. a gift hamper, for recruiting a predetermined number of subjects. This is a controversial approach which could be viewed as a conflict of interest, as it might encourage the enrollment of subjects for whom participation is not in their best interests.

Thanks and Regards

Tarun Wadhwa

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