Protocol Templates, Applications and Guidelines

Templates Suggested templates to be used for the submission of Phase I and II clinical trials Phase I Single Agent Template Version 4.0 (MS Word document) Phase I Combination Template Version 4.0 (MS Word document) Phase I Organ Dysfunction - Renal Template Version 3.0 (MS Word document) Phase I Organ Dysfunction - Hepatic Template Version 3.0 (MS Word document) Phase II Single Agent Template Version 4.0 (MS Word document) Phase II Combination Template Version 4.0 (MS Word document) Adverse Events (AE) Templates Suggested AE templates for studies conducted under a CTEP IND AE Template Phase I Single Agent Version 1.1 (MS Word document) AE Template Phase I Combination Version 1.1 (MS Word document) AE Template Phase II Single Agent Version 1.1 (MS Word document) AE Template Phase II Combination Version 1.1 (MS Word document) Protocol Submission Worksheet v4.2 MS Word document (.doc) format Adobe Acrobat (.pdf) format Synopsis of clinical trials to be submitted with the protocol document Treatment Assignment Instructions and Guidelines Policies and Guidelines for Protocol Development Policy on the Issuance of Waivers for Protocol Deviation(s) Guidelines Regarding Trials Involving Potentially Teratogenic Agents in Men and Women of Reproductive Potential Guidelines Regarding the Inclusion of Cancer Survivors and HIV-Positive Individuals on Clinical Trials Guidelines Regarding the Inclusion of Pregnant and Breast-Feeding Women on Cancer Clinical Treatment Trials Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research Guidelines for Treatment Regimens: Expression and Nomenclature (09/97) Guidelines for Preparing Pharmaceutical Sections (01/06) Guidelines for Correlative Studies in Clinical Trials

Response Evaluation Criteria in Solid Tumors (RECIST) Standard parameters to be used when documenting response for solid tumors Common Data Elements Repository of terms to be used when collecting patient information for clinical trials or cancer care CTCAE (formerly known as CTC) v2.0 and v3.0 Standards used to grade, assign attribution and report side effects experienced by patients on clinical trials CTCAE v3.0 and Lay Term Mapping Document A tool to aid in standardizing lay terms for adverse events in informed consent forms Adverse Event Expedited Reporting System (AdEERS) NCI's web-based system for submitting expedited reports for serious and/or unexpected events to designated recipients and the NCI for all trials using a NCI-sponsored investigational agent Informed Consent Guidelines Suggested templates for describing clinical trial intervention in lay language CTEP Amendment Request Submission Policy (PDF) (Updated May 14, 2004) Policy and standards used to submit protocol amendments Protocol Authoring Handbook (Word) (Updated June 6, 2007) Guidelines and standards used to author and submit LOIs, Concepts, and Protocols. Information on how to interact with CTEP. Cytochrome P450 Drug Interaction Tables

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