A new memo from the DAIDS Office of Clinical Site Oversight (OCSO) notes minor updates to the Site Clinical Operations and Research Essentials (SCORE) Manual. These updates affect the following sections: Investigator Responsibilities, Essential Documents, Essential Documents Recordkeeping Appendix, CRS Facility Requirements, Site Activation Process, Source Documentation Requirements Appendix, and Record Retention.
A new memo from the DAIDS Office of Clinical Site Oversight (OCSO) provides information on the status, plans, and expectations for remote monitoring of studies configured in Medidata Remote Source Review (RSR) and guidance on use of this platform for all DAIDS sponsored studies.
The December 2021 edition of the Monitoring Operations Branch (MOB) newsletter also discusses the expansion of Medidata RSR as well as tips for navigating remote regulatory assessments.
Both resources are posted under the DAIDS Resources section.
The DAIDS Office of Clinical Site Oversight (OCSO) released a new requirement for co-enrollment prevention SOPs at sites, detailed in a memo dated September 8, 2021. The DAIDS SCORE Manual has been updated to reflect the new co-enrollment prevention requirement, and a webinar was hosted on September 28, 2021 to provide additional context. The webinar recording and slides are available on the DAIDS Resources page.
Example co-enrollment prevention SOPs have also been added to the Site Management Resources page.
A summary of the Q&A portion of the webinar is still in development and will be posted on this page once available.
Two new memos are posted under OCSO Resources regarding the recent expansion of remote monitoring for pharmacy source records and revisions to the DAIDS Delegation of Duties Log template.
The DAIDS Office of Clinical Site Oversight (OCSO) Monitoring Operations Branch (MOB) has released the August 2021 edition of the OCSO MOB Newsletter. Highlights from this issue include a recap of the Critical Events Policy obsoletion, an update on remote source document verification efforts, and year-to-date monitoring metrics. Feedback on the newsletter content and/or suggestions are welcome and can be sent to the Monitoring Operations Branch at firstname.lastname@example.org.
Resources from the DAIDS Electronic Information Systems (EIS) Trainings are now available under DAIDS Resources. Materials include presentation slides from the EIS Policy Training, a recording of the training, and links to additional resources provided by DAIDS.
The Office for Policy in Clinical Research Operations (OPCRO), DAIDS is pleased to announce the availability of the updated policy, "Electronic Information System (EIS) Policy” and associated, “Electronic Information System Evaluation Checklist”. This policy has been updated to clarify the scope, and clarify validation responsibilities for non-COTS systems. The associated checklist has been updated with minor changes. The checklist and associated Policy, additional Appendices, and Frequently Asked Questions (FAQs) can be found on the NIAID website.
If you have any questions regarding this associated policy or the associated checklist, please email DAIDSProPEP@mail.nih.gov.
A new frequently asked questions (FAQs) document is now available to address various aspects of Remote Source Document Verification (rSDV). Find the FAQs under the Remote Monitoring and Source Document Verification section.
The HIV/AIDS Clinical Trials Network (ACTG, HVTN, HPTN, IMPAACT, and MTN), DAIDS, and HANC subscriptions to the CITI Program will expire May 31, 2021. After this date, learners will no longer have access to CITI Program courses through their network, DAIDS, or HANC affiliation. These subscriptions will not be renewed beyond May 31, 2021 due to changes in the CITI Program’s pricing structure. This change will not affect access to CITI Program courses through affiliations with other organizations outside of the networks, DAIDS, and HANC, i.e. some universities. Learners who no longer have access to the CITI Program after June 1, 2021 have several options to complete GCP and HSP Training.
The DAIDS is excited to launch the Site Clinical Operations and Research Essentials (SCORE) Manual. The SCORE Manual is a new site-facing resource which consolidates DAIDS operational and procedural requirements to support the implementation of DAIDS-sponsored clinical research within the DAIDS Clinical Trials Networks. The manual serves as a reference describing DAIDS requirements and may be used as a resource for current site staff as well as for on-boarding new research personnel.
The DAIDS Learning Portal is also updated with new and revised trainings to improve adherence to and understanding of DAIDS policies and procedures, and current ICH GCP guidelines.
The Office for Policy in Clinical Research Operations (OPCRO), DAIDS is pleased to announce the availability of the new Electronic Information Systems Policy. This new policy has been developed to ensure consistency of Electronic Information Systems with 21 CFR part 11 and regulatory guidance. The Policy, associated Appendices, Frequently Asked Questions (FAQs) and the Implementation Memo can be found on the NIH website and is also posted in our DAIDS resources page.
Please note that DAIDS plans for a phased implementation of this policy, as described in the Implementation Memo. If you have questions regarding this policy, please review the FAQs. If your query is not addressed in the FAQs, email DAIDSCRSSEISChecklist.email@example.com.