Frequently Asked Questions (FAQ)

Answer: A full rollout of the Agent Accountability (eDARF) module is planned for December 27, 2024. The eDARF module will be available to all sites after this date. Please subscribe to the PMB Listserv to receive future announcements.

Answer: The date has not been determined yet. Use of the Agent Accountability (eDARF) module is voluntary at this time.

Answer: The feasibility of integration of AURORA with other electronic DARF systems will be evaluated. For sites utilizing other eDARF module systems, use of the NCI eDARF module will be required at some point for NCI IND-sponsored trials with PMB-supplied agents. Use of the NCI eDARF system is necessary to integrate with the entire suite of applications in the NCI Clinical Trial Management System.

Answer: While Chrome and Firefox are the preferred web browsers for best performance, AURORA can also be accessed through other browsers such as Microsoft Edge and Safari. However, there may be features that do not perform or display as intended.

Answer: AURORA is record system compliant with GCP and 21CFR Part 11. Saved transactions cannot be undone. PMB does not have the ability to correct site errors. Some errors may be resolved with a subsequent transaction or comment but please report errors to PMB via PMBAfterHours@mail.nih.gov for resolution assistance if needed.

Answer: Review of the AURORA training videos will be a prerequisite to access AURORA at some point in the future. The date has not been determined. The video(s) required to be viewed will be dictated by your user role.

Answer: Site set up is the first action to be taken within AURORA Agent Accountability. No eDARF transactions can be completed in AURORA until site set up is completed.

Answer: Yes. A site currently functioning as a satellite dispensing area of a control and identified as a practice site for one or more registered investigators on the investigator’s FDA Form 1572, must return any agent inventory to the control dispensing area and close out their current satellite eDARFs. The site currently functioning as a satellite dispensing area must set up a PSD, PSD shipping address and PODs in the PSD Worksheet module in AURORA. Each applicable investigator must link the newly created PSD package as a shipping address in their Agent Shipment Form in RCR and submit. Once approved, the site may submit order requests as a control dispensing area and receive agent shipments as a control dispensing area and maintain control eDARFs.

Answer: Yes. Multiple PSD addresses corresponding to an investigator’s practice sites may be identified on the investigator’s Agent Shipment Form in RCR. The PSD packages (PSD, shipping address and PODs) need to be created in the AURORA PSD Worksheet module first if they do not currently exist. The correct shipping address for the investigator must be selected in AURORA at the time of agent order request submission.

Answer: Yes, the same PSD can be assigned to multiple control sites.

Answer: PMB assigned agent lot expiration dates will be updated in the eDARF module when a stock notification letter is issued by PMB. A site can enter a temporary expiration/use by date for any lot without a PMB assigned expiration date. Regardless of who entered the expiration date, the system prohibits dispensing past its expiration date. Once PMB assigns an expiration date, that date cannot be changed and takes precedence over any site entered date.

Answer: Once sites start to use the AURORA eDARF module, all agent final disposition will be performed via Local Destruction request and approval via the eDARF. Returns to the NCI Clinical Repository will not be accepted. Sites not using AURORA eDARF will still need to return agent to the NCI Clinical Repository per the PMB Policies and Guidelines until use of AURORA eDARF is mandatory.

Answer: The co-signer/2nd reviewer may add a comment to the transaction noting verification or approval of a completed transaction if required by site processes.

Answer: Investigators, Primary Shipping Designees, and Primary Ordering Designees identified in the PSD Worksheet for a shipping address must be associated to the investigator’s profile in RCR on the Agent Shipment Form to place orders for PMB-supplied agents in AURORA.

Answer: Yes, PMB will continue to email stock notifications of the 5 letter subtypes to appropriate site personnel: expiration, protocol status, recall, IND withdrawal, and extension of expiration.

Answer: The help button on the AURORA dashboard provides step-by-step help. The NCI/CTEP AURORA Training video series in the CLASS Learning Management System also provides detailed guidance. For issues related to AURORA, please contact PMBAfterHours@mail.nih.gov. Include AURORA in the subject line.