DCP Acronym List, Consortia 2012 (DOC, 63 KB)
See SOP Documents, DCP Guidance Documents and additional resources linked by topic within the tabs below.
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Developing
Conducting
Monitoring
Closing Out
Regulatory
- SOP 1: Regulatory Documents (DOC, 35 KB)
- SOP 1a: Transmittal Form for Submitting Regulatory Documents (DOC, 31 KB)
- FDA Form 1572 (Statement of Investigator) (PDF, 375 KB)
- DCP Financial Disclosure Form (PDF, 221 KB)
- DCP Delegation of Tasks Form (DOC, 43 KB)
Investigational Agent Distribution
Study Initiation Meeting
- SOP 2: Study Initiation Meeting (DOC, 32 KB)
- SOP 2a: Study Initiation Meeting Report (DOC, 54 KB)
Recruitment, Retention and Adherence
- SOP 6: Participant Recruitment, Retention and Adherence (DOC, 38 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
Source Documentation
- DCP Guidance Document on Source Documentation (DOC, 48 KB)
Baseline and Adverse Event Reporting
Adverse Events
- SOP 3: Reporting Serious Adverse Events (DOC, 69 KB)
- DCP Serious Adverse Events Reporting Form (DOC, 209KB)
- DCP Consortia Serious Adverse Events Reporting Form Instructions for Completion (DOC, 68 KB)
Protocol Deviations
- SOP 4: Reporting Protocol Deviations (DOC, 30 KB)
- DCP Consortia Protocol Deviation Form (PDF, 1.9 MB)
Case Report Forms
- SOP 5: Case Report Forms (DOC, 39 KB)
- Case Report Forms (CRFs) (DOC, 187 KB)
- CRF Instructions (DOC, 350 KB)
Recruitment, Retention and Adherence
- SOP 6: Participant Recruitment, Retention and Adherence (DOC, 38 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
- SOP 9: Site Preparations for Monitoring and Auditing Visits (DOC, 27 KB)
- SOP 10: CLO Oversight of Participating Organizations (DOC, 31 KB)
CLO Monitor
- SOP 11: CLO Monitor Qualifications (DOC, 23 KB)
- SOP 11a: CLO Monitor Qualifications Checklist (DOC, 212 KB)
- SOP 12: CLO Monitor Instructions for Conducting Monitoring Visits (DOC, 39 KB)
- SOP 12a: Monitoring Visit Report Template (DOC, 82 KB)
- SOP 12b: Monitoring Visit Log (DOC, 27 KB)
- SOP 12c: Action Item Site Response Form (DOC, 23 KB)
Closing Out
- SOP 13: Site Preparations for Study Closeout (DOC, 46 KB)
- SOP 13a: Study Closeout Checklist (DOC, 33 KB)
- SOP13b: Final Dataset and Documentation Submission Summary (pending)
- SOP 14: CLO Monitor Instructions for Conducting Closeout Visits (DOC, 37 KB)
- SOP 14a: Closeout Visit Report Template (DOC, 50 KB)
- DCP Protocol Status Update Form (DOC, 37 KB)
- DCP Return Agent Form (DOC, 30 KB)
Please email dcphelpdesk@dcpais.com if you have any questions or concerns.