Written by Anay Moscu, PharmD, BCPS, BCOP, ACPR-CP
At the 2023 Research Pharmacy Summit, Dr. Anay Moscu, Director of Pharmacy – Outpatient Infusion Services at Moffitt Cancer Center, moderated the discussion, “How do you navigate protocol training documentation?” In today’s blog, Anay continues this engaging conversation by offering an approach for developing the best pharmacy protocol training documentation and maintenance process for your IDS site.
Questions to Consider when Developing a Documentation Process for your Site
The key to creating an effective pharmacy protocol training documentation and maintenance process for your site is to create a process that is sustainable for your current research pharmacy model and aligns with both institutional and regulatory requirements. Here are some questions for you to consider to get you started.
Q: What is your pharmacy practice model for supporting clinical trials at your site?
Depending on your practice model, you either have a dedicated Investigational Drug Service (IDS) team that supports all aspects of research or a hybrid IDS model where certain tasks are delegated to non-research pharmacy staff.
Q: What are the required qualifications for both research and non-research staff involved in investigational medication dispensing and how do we train and maintain documentation?
The FDA guidance on investigator responsibilities allows clinical trial tasks to be delegated to qualified individuals. Per sec 4.6.2 of ICH(GCP), where allowed /required, investigators should assign some or all duties for investigational drug accountability to the appropriate pharmacist or another individual who is under the supervision of the investigator/institution.
All pharmacy staff involved in dispensing investigational drug products (IDS and non-IDS) should have the following documented training:
- Good Clinical Practice (GCP)
- Applicable institutional policies and competencies (i.e., IDS processes/SOP’s, USP 797/800, conflicts of interests)
IDS Staff should also have the following documented training per ASHP IDS Guidelines:
- Human Subject Protections and Belmont report
- Additional sponsor requirements (i.e., NCI CTEP)
IDS should develop and maintain protocol-specific dispensing guides to be utilized by non-IDS pharmacy staff involved in dispensing investigational drug products.
- Define staff qualifications and training within your institutional SOP’s so that you may share them with sponsors and during FDA audits.
- Update protocol-specific dispensing guidelines as applicable with protocol amendments, pharmacy manual updates, etc.
- Ensure the most current protocol-specific dispensing guidelines are accessible to pharmacy staff involved in dispensing.
Q: Who should sign the Delegation of Authority (DOA) for a given clinical trial?
Both the FDA and ICH/GCP require investigators to maintain a list of appropriately qualified persons to whom they have delegated trial-related tasks. This list is often referred to as the Delegation of Authority, Responsibilities, or Duties log.
This log will indicate tasks that are related to investigational drug product dispensing and overall drug accountability. These corresponding sections will need to be signed by assigned staff for that trial.
If you have a small research operation, it may be feasible to have all staff attend the site initiation visits (SIV), amendment training, and sign the DOA. If you have a larger operation and team, that becomes impossible to execute. IDS Pharmacy technicians who have delegated tasks for a study work under the supervision of an IDS pharmacist should not need to sign a DOA as per NCCN IDS Consensus. Non-research staff such as compounding and satellite staff and pharmacy residents working within their scope practicing under the authority of IDS, should not need to sign a DOA. Refer to institutional policies on their training and maintenance.
- Consider assigning a lead pharmacist to sign the DOA log, who is then responsible to “training” the IDS team vs. all IDS staff signing
- Work with your clinical trial office to incorporate into the DOA SOP, this may be beneficial for all other ancillary departments (i.e., nursing, radiology, laboratory, tissue core, etc.)
Q: How do you best maintain pharmacy protocol training documentation?
In terms of training documentation, consider these time points:
- Onboarding new staff
- Annually (USP 797/800)
- Triennial (once every three years, GCP etc.)
- Protocol specific: prior to study activation, treating the first patient, with each amendment, pharmacy manual update., etc.
To capture and maintain training documentation, an electronic system such as a clinical trial workflow platform already used by your institution, or an IDS-focused software would be ideal. These systems can automate training, send notifications, and even prevent access to a specific trial unless training has been acknowledged.
Less ideal would be to include a manual process by maintaining and scanning paper logs into a shared drive. Also, emailing with a voting feature to acknowledge training can accomplish this task. Depending on the size of your team and clinical trial portfolio, some of these methods would not be practical.
- Consider defining within your SOP that staff processing research patients will use the most recent version of the protocol and pharmacy manual and perform self-training prior to processing their first patient on trial. Attestation of this training can be provided upon request.
- Consider adding a statement to source documents being utilized and signed by staff. For example, for a compounding/preparation form, include the statement “Documents training of the protocol.”
Remember, the key is to create a process that is sustainable for your current model and have SOPs in place that define your practice.
Thank you Dr. Moscu for participating in the Research Pharmacy Summit and for following up with these great insights. We look forward to learning more from you in the future.