- Consortia Organizational Rosters
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- Protocol Development
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- Protocol Appendix: Alcohol and Tobacco Assessment CRFs
- Spanish Translation of Protocol Appendix: Alcohol and Tobacco Assessment CRFs
- DCP Consortia Additional Study Related Documents Template
- Multi-Institutional Monitoring Plan (MIMP) (pending)
- Data and Safety Monitoring Plan (DSMP) (pending)
- Protocol Status and Amendments
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- Adverse Events and Protocol Deviation*
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(NOTE: This form must be completed using Adobe Acrobat Reader DC. It may be downloaded here: https://get2.adobe.com/reader/otherversions/)
COVID-19 Memorandum for Division of Cancer Prevention Investigators
MEMORANDUM
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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
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- Investigator Registration and Delegation of Tasks Log
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- FDA Form 1572 (Statement of Investigator) (PDF, 1.4 MB)
- Monitoring
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- Reports
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Please e-mail dcphelpdesk@dcpais.com if you have any questions or concerns.