Clinical Trial Protocol Template

Clinical Trial Protocol Template. Each Investigator participating in the clinical trial and the associated clinical study staff will receive training on the clinical protocol. To download this template, you will need access to SharePoint.

Generic Protocol Documents and Instructions for CTEP Studies. Create a subject visit template to facilitate consistent application of the protocol across sites and subjects. Developed jointly by the FDA and NIH, the new clinical trial protocol template is now available for applicants seeking Investigational Device Exemption (IDE) or Investigational New Drug (IND) approvals.

Background All randomized clinical trials (RCTs) require a protocol; however, numerous studies have highlighted protocol deficiencies.

Each Investigator participating in the clinical trial and the associated clinical study staff will receive training on the clinical protocol.

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Free Clinical Trial Templates | Smartsheet

Example clinical trial protocol biologic

Clinical Trials Office (CTO)

These clinical protocol templates can be accessed via the secure web-based e-Protocol Writing Tool and as Word templates. Such prospective biomedical or behavioral research studies on human participants are designed to answer specific questions about. NCI Informed Consent Template for Adult Cancer Trials using the ETCTN Biorepository and/or National Clinical Laboratory Network (NCLN) (MS Word) — ETCTN investigators utilizing the ETCTN Biorepository and/or NCLN should.