NOTE: If you cannot open a PDF file
- Right click on link
- In the pop-up menu, click "Save link as" or "Save target as"
- In the following "Save file/Save as" dialog box, browse to the location where you would like to save the file and click “Save”
- After the file has saved, to open and view in PDF do the following:
- Browse to the location of the PDF and double-click to open it in Acrobat, or
- Open the PDF from within Acrobat directly, by clicking the "File" menu and selecting "Open", then browse to and select the PDF, and click "Open".
See Adobe's Display PDF in browser to learn how each browser has its own setting to control how PDFs open from a webpage.
Consortia Organizational Rosters
- Guidelines for Modifying a Consortium Roster (DOC, 23 KB)
- Task Order Technical Proposal Submission Form (DOC, 37 KB)
- DCP Consortia Protocol Submission Worksheet (
DOC, 64 KB)
- DCP Consortia Protocol Template (
DOC, 122 KB)
- Protocol Appendix: Alcohol and Tobacco Assessment CRFs
- Alcohol Tobacco Questionnaire Instructions (DOC, 14 KB)
- Alcohol Assessment - Baseline (DOC, 38 KB)
- Alcohol Assessment - Follow-up (DOC, 37 KB)
- Tobacco Assessment - Baseline (DOC, 41 KB)
- Tobacco Assessment - Follow-up (DOC, 38 KB)
- National and Local Resources to Help with Alcohol Abuse and Alcoholism (DOC, 20 KB)
- Consortia Informed Consent Letter (DOC, 43 KB)
- DCP Informed Consent (IC) Template (DOC, 150 KB)
- DCP Consortia Additional Study Related Documents Template
- Recruitment, Retention, and Adherence Plan Outline Template (PDF, 950 KB)
- Pharmacokinetic and Biomarker Method Development Report (DOC, 69 KB)
- Case Report Forms (CRFs) (DOC, 187 KB)
- CRF Instructions (DOC, 350 KB)
- Data Management Plan (DMP) (DOC, 77 KB)
- Multi-Institutional Monitoring Plan (MIMP) (pending)
- Data and Safety Monitoring Plan (DSMP) (pending)
Protocol Status and Amendments
- DCP Protocol Status Update Form (DOC, 37 KB)
- Revision or Amendment Submission Checklist For DCP Chemoprevention Studies (DOC, 31 KB)
Adverse Events and Protocol Deviation *
- DCP Consortia Serious Adverse Events Reporting Form (DOC, 208 KB)
- DCP Consortia Serious Adverse Events Reporting Form Instructions (
DOC, 68 KB)
- DCP Consortia Protocol Deviation Form (PDF, 2.03 MB)
(NOTE: This form must be completed using Adobe Acrobat Reader DC. It may be downloaded here: https://get.adobe.com/reader/otherversions/)
COVID-19 is an emerging, rapidly evolving situation.
- COVID Minor Deviation Reporting Form (
XLS, 74 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.
- DCP Policy and Guidelines for Investigational Agent Distribution (DOC, 30 KB)
- DCP Guidelines for Submitting Clinical Drug Requests (DOC, 27 KB)
- DCP Return Agent Form (DOC, 30 KB)
- DCP Guidelines for Submitting Study Site Inventory (DOC, 26 KB)
- DCP Form for Submitting Study Site Inventory (DOC, 42 KB)
- DCP Drug Request Form (DOC, 42 KB)
- FDA Form 1572 (Statement of Investigator) (PDF, 1.4 MB)
- DCP Financial Disclosure Form (PDF, 221 KB)
- DCP Delegation of Tasks Log (DOC, 75 KB)
- Minimum Data Set Instructions (DOC, 426 KB)
Please e-mail email@example.com if you have any questions or concerns.