This section captures Q&A covered during the Division of AIDS (DAIDS) SCORE Manual sessions on February 9, 2021 and February 11, 2021. Additional information from the session, including a full recording and slides, can be found on the DAIDS Resources page under DAIDS Presentations.
Per the Destruction of Clinical Trial Specimens Owned by NIAID SOP, ‘unless otherwise stated, specimens collected by contractors are the property of the NIAID; specimens collected by grantees (including cooperative agreements) are the property of the awardee institution.’ The SOP does not apply to specimens collected in the DAIDS clinical trial networks. Sites should refer to protocol SSP and their respective Lab Centers (LCs) for further information on this topic.
If the labs are storing specimens owned by NIAID, the process described in the SOP should be followed. For specimens not owned by NIAID, site labs should refer to protocol SSP and their respective Lab Centers (LCs) for further information on this topic.
Equipment and Electronic Systems
Sites are expected to have a procedure in place to certify equipment and ensure calibration of equipment on a recurring schedule that is consistent with institutional policies. Sites have flexibility to determine what the minimum frequency for certification is and are responsible for ensuring this aligns with institutional policies. For situations where sites are not in control of the maintenance and/or calibration process(es) or records, the site may defer to the parent institution's SOP(s) in place of having a CRS specific SOP. Under these circumstances, the CRS should be able obtain a copy of the SOP or the maintenance/calibration records in a timely manner if requested by a monitor for an Operations Assessment or by an inspector during a Regulatory Inspection. For Operations Assessments conducted by monitors, these records are requested 15 working days in advance in the pre-visit letter. When records are requested as part of a Regulatory Inspection, the site must have a process in place whereby they can obtain requested records in a timely manner (typically within 24 hours). The process for obtaining records from outside the CRS during an inspection should be included in the site's Regulatory Inspection Preparedness SOP.
Electronic signatures are allowed on DoD logs. The SCORE Manual does not address electronic signatures on DoD logs specifically, however electronic signatures are covered in the new Electronic Information Systems (EIS) Policy which details specific requirements (ex. CFR Part 11) that must be met to use electronic signatures.
The DAIDS Office for Policy in Clinical Research Operations (OPCRO) are planning to develop materials to provide sites and network colleagues an overview and training on the EIS policy in approximately mid-2021. Until the training is released, sites can reference the EIS policy and related FAQs on the NIAID website.
The SCORE Manual will expand on these topics in future versions. DAIDS only recently expanded the requirement for rSDV, at which point the SCORE Manual was already finalized. Future versions of the SCORE Manual will be updated to include rSDV and other topics.
For e-consent, DAIDS does not have a specific reference aside from CFR Part 11, and DAIDS does not have a platform currently to support this in a cross-network manner. The Informed Consent section of the manual includes an embedded section titled Electronic Informed Consent Guidance.
At this time, we are not aware of any plans to support an electronic consent platform like what the FDA has created via phone application.
This was intentional. When DAIDS reviewed all DLP trainings in 2020, some trainings were updated for content, some new trainings were added, and a few trainings were removed because they did not add any educational value beyond that of simply reading the policy. If sites want additional training on certain topics, please communicate your request to your DAIDS Program Officer. Sites also have several training resources available, including a listing of all trainings associated with SCORE manual content, and a list of all DAIDS-required trainings.
Yes, since the content of many trainings have been updated, site staff must retake the trainings on the DLP as indicated on the DAIDS required training page. This page on the DLP lists all trainings required, who must take them, and whether the training requirement applies to existing sites or only new sites.
Certain DAIDS-required trainings, such as Human Subjects Protection (HSP) and Good Clinical Practice (GCP), expire every three years and must be renewed prior to their expiration. However, the other new and updated trainings on the DAIDS Learning Portal do not expire. Because the content of the other DAIDS required trainings on the DLP have been updated, sites are required to retake them now with the start of this new grant cycle. Please reference the DAIDS Learning Portal site, which includes a resource that outlines which trainings are required and who should take them.
No. DAIDS required HSP and GCP trainings do not need to retaken at this time if site staff have taken them within the past 3 years. Trainings for DAIDS Systems such as CSM, DAERS, DPRS, also do not need to be repeated if the trainings were previously completed and the staff member already has access to the CRMS modules. However, for other new and updated DAIDS trainings that now have new content, site staff are required to complete those trainings as part of the requirements of the CTU transition packet checklist. Please see the DAIDS required training page for more details.
The CSM training, like DAERS training, is only required for staff at new sites or new staff at existing sites. For CSM, this includes anyone interacting with the monitors, monitoring reports or performing issue resolution within the system.
No, not at this point. The DAIDS Required Training page includes a list of all the required trainings, which personnel should be taking each training, and whether the training is new to DAIDS sites from the last recompetition.
Standard Operating Procedures (SOPs)
No, sites are not required to use the DAIDS templates. DAIDS templates, which are modifiable documents are provided to sites as guidance to assist sites in developing their own SOPs. Whatever the format used, sites must ensure the documents meet all DAIDS requirements and are version controlled.
The SCORE Manual includes a high-level SOP template which provides a general format for all SOPs however, sites are not required to use this template. In addition to the general template, the SCORE Manual includes specific templates for the Regulatory Inspection Preparedness and the Age and Identity Verification Process SOPs which highlight key points to be included. There is also a CRS guidance for the development of an Age and Identity Verification SOP that describes key points that should be considered and included. For the other topics covered under the List of DAIDS Required Site SOPs, DAIDS does not provide key points to be addressed in each of those SOPs. However, the HIV/AIDS Clinical Trials Networks often require similar SOPs and they may provide templates.
DAIDS does provide specific SOP templates for the Regulatory Inspection Preparedness SOP and the Age and Identity Verification process SOP. DAIDS does not provide content specific templates for the other required site SOPs or the required Pharmacy SOPs. The HVTN however publishes SOP templates and those have been made available by HANC.
The requirement to submit specific SOPs for DAIDS approval is described in the CTU transition packet checklist which was distributed to all HIV/AIDS Network clinical research sites in January 2021. Please follow-up with your DAIDS PO regarding any specific due dates for SOPs.
No, as long as the Network provided DOD template includes all of the fields from the DAIDS DOD Log Template. If all of the required fields are not present the site will be out of compliance with DAIDS requirements.
If your site was fully funded as part of the 2020 HIV/AIDS Network Clinical Trials Unit Recompetition, DAIDS requires submission of an updated SOP on the site’s informed consent process. If the site is a protocol specific site, participant enrollment has completed for all DAIDS sponsored HIV/AIDS Network protocols at the site, and there are no further protocols planned for implementation at the site, please contact your DAIDS Program Officer to determine whether submission of updated SOPs on the informed consent process is required. This will depend on the overall protocol status in terms of enrollment completion and participant status, as there can be changes in protocols or amendments that require reconsenting. Sites which are only participating in the REPRIEVE study are exempt from the requirement to submit SOPs to DAIDS as well as other DAIDS transition requirements in the 2020 CTU grant cycle.
Only the 3 SOPs required to be submitted to DAIDS need to be in English.
The SCORE Manual does not include a section on Clinical Trial Insurance (CTI). NIAID's Grants Management Program has created guidance for all Networks including a checklist for sites to review when they request to use grant funds for CTI.
The SCORE Manual is focused on operational procedures and does not include grants management policies or procedures. There are other vehicles outside the SCORE Manual that describe requirements for management of US federal funds.
The requirements in the SCORE Manual will apply to NICHD sites participating in DAIDS sponsored HIV/AIDS Network clinical trials , so NICHD sites should expect to hear from their Westat point of contact to collect the same information that DAIDS staff are requiring from DAIDS sites.
Sites will need to submit their QA summaries at the end of April 2021 to their DAIDS Program Officer. The QA Summary should reflect the quality assurance activities conducted and data collected over the reporting period. The reporting period must cover a minimum of 3 consecutive months in the past year. Sites are welcome to report on a longer period if they choose, but a minimum of 3 months is required. Any consecutive 3-month period of time in the past year is satisfactory. Ordinarily, the QA Summary Reports are submitted twice a year by June1 and December 1. DAIDS delayed the report that is normally due on December 2020 to April 30, 2021 (See DAIDS CQMP QA Summary Report: December 2020 Submission Requirements Memo).
DAIDS acknowledges the challenge of working with multiple institutes and sponsors in this environment, and the lack of a centralized information system that captures common site information. Given the current resources and integration of information systems, sites may have to provide information separately to the multiple networks they are working with.
Yes, a separate signature log is reasonable. Please remember that the investigator has to initial next to each staff member listed and sign/date the form.
Per the SCORE Manual Section on CRS Personnel Qualifications, Training and Responsibilities:
If there is a change of PI/IoR, the new individual in the role should review the DoD log, initial, and date next to all previous PI’s/IoR’s initials as an agreement with each delegated duty/task. Any changes should be specified in a new line. In addition, the new PI/IoR should write a note in the comments section that they reviewed the log and agree with tasks delegated by the previous PI/IoR or clarify any changes in the delegated tasks fields. The new PI/IoR must sign and date this note. Alternatively, the new PI/IoR may complete a new DoD log, in which case, the outgoing PI/IoR must close out the DoD by:
- Completing end dates for all site staff, and initial/date the DoD log in the respective field
- Completing the end date on the investigator statement page and signing/dating the date entry
- Writing in the comments section the PI/IoR change as “effective on” and that a new version of the DoD has been created