DCP Acronym List, Consortia 2012 (
See SOP Documents, DCP Guidance Documents and additional resources linked by topic within the tabs below.
Developing
Regulatory
- SOP 1: Regulatory Documents (
DOC ,124 KB ) - SOP 1a: Transmittal Form for Submitting Regulatory Documents (
DOC ,31 KB ) - FDA Form 1572 (Statement of Investigator) (PDF, 1.4 MB)
- DCP Financial Disclosure Form (
PDF ,221 KB ) - DCP Delegation of Tasks Log (
DOC ,38 KB )
Investigational Agent Distribution
Study Initiation Meeting
- SOP 2: Study Initiation Meeting (
DOC ,33 KB ) - SOP 2a: Study Initiation Meeting Report (
DOC ,54 KB )
Recruitment, Retention and Adherence
- SOP 6: Participant Recruitment, Retention and Adherence (
DOC ,39 KB ) - Recruitment, Retention, and Adherence Plan Outline Template (
PDF ,950 KB ) - AQuIP Online Accrual Reporting System (OARS)
- Training Demonstration Webinar | AQuIP OARS User Guide(PDF, 1.1 MB)
- DCP AQuIP Website: www.dcpaquip.com
Conducting
Source Documentation
- DCP Consortia Source Documentation Guide (
DOC ,48 KB )
Baseline and Adverse Event Reporting
Adverse Events
- SOP 3: Reporting Serious Adverse Events (
DOC ,68 KB ) - DCP Serious Adverse Events Reporting Form (
DOC ,209 KB ) - DCP Consortia Serious Adverse Events Reporting Form Instructions (
DOC ,69 KB )
Protocol Deviations
- SOP 4: Reporting Protocol Deviations (
DOC ,34 KB ) - DCP Consortia Protocol Deviation Form (
PDF ,3 MB )
(NOTE: This form must be completed using Adobe Acrobat Reader DC. It may be downloaded here: https://get2.adobe.com/reader/otherversions/)
COVID-19 is an emerging, rapidly evolving situation.
MEMORANDUM
- COVID Minor Deviation Reporting Form (
XLS ,74 KB )
Date: May 8, 2020
Case Report Forms and SVAR Template
- SOP 5: Case Report Forms (
DOC ,154 KB ) - Case Report Forms (CRFs) (
DOC ,68 KB ) - CRF Instructions (
DOC ,191 KB ) - 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 )
- Alcohol Tobacco Questionnaire Instructions (
- 2012 Consortia SVAR Template (
XLS ,114 KB )
Recruitment, Retention and Adherence
- SOP 6: Participant Recruitment, Retention and Adherence (
DOC ,39 KB ) - Recruitment, Retention, and Adherence Plan Outline Template (
PDF ,950 KB ) - AQuIP Online Accrual Reporting System (OARS)
- Training Demonstration Webinar | AQuIP OARS User Guide(PDF, 1.1 MB)
- DCP AQuIP Website: www.dcpaquip.com
Communication
DCP Consortia SOPs
Monitoring
Monitoring
- SOP 9: Site Preparations for Monitoring Visits and Quality Assurance Audits (
DOC ,32 KB ) - SOP 9a: Site Preparations for Quality Assurance Monitoring Audits (
DOC ,30 KB ) - SOP 10: CLO Oversight of Participating Organizations (
DOC ,31 KB )
CLO Monitor
- SOP 11: CLO Monitor Qualifications (
DOC ,24 KB ) - SOP 11a: CLO Monitor Qualifications Checklist (
DOC ,23 KB ) - SOP 12: CLO Monitor Instructions for Conducting Monitoring Visits (
DOC ,41 KB ) - SOP 12a: Monitoring Visit Report (
DOC ,76 KB ) - SOP 12b: Monitoring Visit Log (
DOC ,27 KB ) - SOP 12c: Action Item Site Response Form (
DOC ,24 KB )
Closing Out
Closing Out
- SOP 13: Site Preparations for Study Closeout (
DOC ,49 KB ) - SOP 13a: Study Closeout Checklist (
DOC ,35 KB ) - SOP 13b: Final Dataset and Documentation Submission Summary (
PDF ,258 KB )
NOTE: If this document fails to open in your current browser, please (1) try another browser or (2) save the file locally and open it with Adobe Acrobat Reader. - SOP 13c: Material Transfer Manifest for Biospecimen Submission (
XLS ,61 KB ) - SOP 13d: Study Unblinding Worksheet (
XLS ,51 KB ) - SOP 14: CLO Monitor Instructions for Conducting Closeout Visits (
DOC ,39 KB ) - SOP 14a: Closeout Visit Report Template (
DOC ,51 KB ) - DCP Protocol Status Update Form (
DOC ,34 KB ) - DCP Return Agent Form (
DOC ,17 KB )
Please e-mail dcphelpdesk@dcpais.com if you have any questions or concerns.