Clinical Trial Protocol Amendment Template. Strict inclusions and exclusion criteria reduce the available patient pool for Due to unforeseen circumstances, a clinical protocol amendment may be necessary. Clinical trial protocols have inclusion and exclusion criteria to qualify patients.
Any amendment(s) should also bear the amendment number(s) and date(s). (NOTE: Since the protocol and the clinical trial/study report are closely related, further relevant information can be found in the ICH Guideline for Structure and.
Protocol amendment must be again approved by the Ethics Committee.
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TEMPLATES: For an example of a protocol format that complies with ICH GCP requirements, please refer to this template Protocol title, protocol identifying number, and date. This protocol template aims to facilitate the development of two types of clinical trials involving human participants. You need to send a notification of amendment form, a revised application.
