The DF/HCC clinical research Standard Operating Procedures (SOPs) listed below have been revised. In accordance with ADM-100, these changes were drafted by the Clinical Research Operations Committee and have been approved by DF/HCC leadership. When applicable, training on an updated SOP may be required, and should be documented according to the requirements in EDU-100.
The approved updates to the SOPs will go into effect on August 31st, 2017.
Tracked changes have been posted to the DF/HCC website to facilitate notification and review:http://www.dfhcc.harvard.edu/research/clinical-research-support/document-library-forms-sops-etc/sop-updates/
Summary of the Changes and Training Requirements
(Please note that this is not a comprehensive list of all changes, but a summary of significant updates.)
Significant Changes: Formal Training Required*
MULTI-100: Conducting DF/HCC Investigator-Sponsored Multi-Center Trials
- This SOP has been edited throughout due to the implementation of an improved multi-center trial review and approval process.
- Section 5.1 has been updated to outline the new institutional approval requirements, and remove references to the Multi-Center Coordinating Committee (MCC) and MCC-required submission documents.
- Section 5.1 has also been updated with a small clarification on the existing training requirement for new DF/HCC Sponsors of multi-center research, as coordinated by the Office of Data Quality (ODQ)
- For more information on the new multi-center approval process, please visit the new ODQ Multi-Center Trials page.
*Formal training or re-training on this SOP is only required for research personnel involved in the conduct of DF/HCC Investigator-Sponsored Multi-Center Trials.
Content and Administrative Updates: No Formal Training Required
INV-100: Research Pharmacy Standard Policy
- Updated throughout to reflect consensus requirements across DF/HCC institutional research pharmacies, including:
- Section 5.1: Elements of the standardized Drug Accountability Record Form (DARF) across DF/HCC research pharmacies, and drug accountability maintenance requirements
- Section 5.5 and 5.6: Clarification on investigational product handling requirements including handling, storage and destruction of investigational drugs per institutional policy.
- Section 5.7: Clarification on disposition requirements for unused or expired investigational drugs per institutional policy.
- 5.8: Clarification that external sponsors conducting routine monitoring visits to any DF/HCC research pharmacy must do so in accordance with MON-101 and DF/HCC Operations: Mandatory Research Pharmacy Standard Procedures (new).
INV-101: Transfer of Investigational Drugs
- Section 18.104.22.168.3: NCI Drug Accountability Record (NCI DAR) changed to Drug Accountability Record to account for studies not using a NCI DAR.
- Section 22.214.171.124.1: Used vials and bottles of liquid (in addition to syringes) will not be collected from the subject.
INV-102: Return of Unused Investigational Drug from Subject to Pharmacy
- Section 5.4: Updated to reflect institution specific policies for the return and destruction of unused investigational drug to the DFCI, MGH, and BIDMC research pharmacies.
REGIST-200: ClinicalTrials.gov Registration and Maintenance
- Combined with REGIST-201: Posting Results and Adverse Events on ClinicalTrials.gov.
- Updated throughout to reflect new federal regulations pertaining to ClinicalTrials.gov reporting, specifically related the HHS Final Rule and the NIH Policy requiring enhanced registration and reporting requirements, effective 1/18/17.
- Due to the above regulations, major revisions were required to the results reporting requirements for applicable trials.
Additional Document Updates – Effective 8/31/17 unless otherwise noted
SOP Training Record
- Updated to remove newly retired REGIST-201.
DF/HCC Operations: Mandatory Research Pharmacy Standard Procedures (effective 6/30/17)
- Created to outline mandatory processes and procedures across the DF/HCC Research Pharmacies, in accordance with updates to INV-100.
DF/HCC Operations: Review and Approval of Investigator-Sponsored Multi-Center Trials
- Converted from the previous DF/HCC Guidance: Procedures for Submission of Investigator-Sponsored Multi-Center Protocols to reflect the new approval process for multi-center trials in MULTI-100.
Institutional Approval Form for DF/HCC Investigator-Sponsored Multi-Center Trials
- New Multi-Center Trial approval form to go along with the new approval process in MULTI-100.
Newly Retired SOPs – Effective 8/31/17
REGIST-201: Posting Results and Adverse Events on ClinicalTrials.gov (combined with REGIST-200).