CP-CTNet Organizational Rosters
- CP-CTNet Roster Management System
- Guidelines for Modifications to a Lead Academic Organizational Roster (
DOC ,26 KB )
Protocol Development
- CP-CTNet Concept Submission Form (
DOC ,52 KB ) - CP-CTNet Concept Budget Template (
DOC ,27 KB ) - CP-CTNet Protocol Submission Worksheet (
DOC ,26 KB ) - CP-CTNet Protocol Budget Submission Instructions (
DOC ,17 KB ) - DCP CP-CTNet Chemoprevention Protocol Template (
DOC ,231 KB ) - Spanish Translation of Protocol Appendix: Alcohol and Tobacco Assessment CRFs
- Instructions for Submitting Spanish Translation Documents to the CIRB (
DOC ,19 KB ) - Translated Alcohol and Tobacco Assessment CRFs and National and Local Resources to Help (
DOC ,78 KB ) - Alcohol and Tobacco Certificate of Accuracy (
PDF ,126 KB ) - Translated Instructions for the Evaluation of COVID 19 (
DOC ,23 KB ) - COVID Assessment Certificate of Accuracy (
PDF ,127 KB )
- Instructions for Submitting Spanish Translation Documents to the CIRB (
- DCP CP-CTNet Informed Consent Template (
DOC ,157 KB ) - Additional Study Related Documents
- CP-CTNet Rapid Response Restricted Funds Biomarkers (
DOC ,27 KB ) - CP-CTNet IRB memo (
DOC ,41 KB )
NCI Registration and Credential Repository (RCR) Links and Delegation of Tasks Log
- Identity and Access Management (IAM)
- Registration and Credential Repository
- RCR Help Desk
- CP-CTNet Delegation of Tasks Log (
DOC ,39 KB ) - CP-CTNet Delegation of Tasks Log - Site Principal Investigator (
DOC ,37 KB ) - CP-CTNet Delegation of Tasks Log - Individual Staff (
DOC ,36 KB ) - DCP Delegation Task Log Master Task List (
DOC ,28 KB )
Protocol Status and Amendments
- Protocol Status Update Form (
DOC ,34 KB ) - Revision or Amendment Submission Checklist for DCP Chemoprevention Studies (
DOC ,20 KB )
Adverse Events and Protocol Deviations *
- DCP Baseline and Adverse Event (AE) Reporting Guidelines (
DOC ,36 KB ) - DCP Serious Adverse Events Report Form (
DOC ,101 KB ) - DCP Serious Adverse Events Report Form Instructions (
DOC ,71 KB ) - Protocol Deviation Notification Form (PDF, 2.8 MB)
COVID-19 Memorandum for Division of Cancer Prevention Investigators
MEMORANDUM
- COVID Minor Deviation Reporting Form (
XLS ,75 KB )
Date: May 8, 2020
* PLEASE NOTE: This is a reminder that infections occurring in subjects on clinical trials are considered adverse events and should be reported per protocol guidelines via normal procedures (via the MDS and via the SAE forms if serious).
Please document COVID-19 related adverse events as follows:
- "Infections and infestations -Other, specify" in the Adverse Event field and "COVID-19" under the "Adverse Event Verbatim Term";
- Please specify "documented" or "suspected" in the "Adverse Event Verbatim Term" (e.g., "COVID-19 - suspected" or "COVID-19 – documented" in the Verbatim Term).
- Additionally, please record (and if applicable, report via the SAE form) any other Adverse Events the subject experiences such as Dyspnea, Acute respiratory distress syndrome, etc.
SAE specific instructions (this process is the same as our usual process):
Narrative: Identify all pertinent facts related to the COVID-19 infection including, but not limited to the following:
- Presumptive vs confirmed diagnosis. If presumptive, please update your narrative if/when diagnosis is confirmed, including timelines;
- Treatment information;
- Recovery information, including timelines;
- Outcome information/status; and
- Supporting documentation: Please include supporting documentation including admission notes, progress notes, clinical visits, and discharge summary if/when available.
Agents/Drugs
- DCP Returned Agents List (
DOC ,17 KB ) - Investigational Agent Request (
DOC ,23 KB )
CP-CTNet SOPs and Related Documents
- The CP-CTNet SOPs and Related Documents are housed on the DMACC page.