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.firstname.lastname@example.org.