Stage-I: Documentation in clinical trials

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Dear Participants,

Documents including patient screening forms, informed consent, patient enrollment, etc should be maintained properly in accurate manner considering all regulatory requirements and protocol specifications.

Let us talk about some of the important documents and importance of documentation.

Patient screening form is a document which requires following information to be included to satisfy the criteria:

Medical/medication history

Presenting complaints

Diagnosis or current medical condition

Vitals or physical examination

Other relevant lab investigations (to confirm inclusion/exclusion)

Inclusion/exclusion criteria

Ability to sign the consent

Once the patient satisfies the screening requirements then patient can be considered for informed consent.

Tarun Wadhwa