Today's blog was submitted by guest blogger, Melissa Byrn. Melissa is affiliated with the Office of Clinical Research at a large academic research organization and will be contributing blogs to IMARC Research.
If you’ve worked in clinical research for more than a day, I do not need to tell you about the challenges of developing and managing the relationship between clinical trial sites and sponsor/clinical research organizations (CROs).
Sponsor/CROs are in the unique position of visiting sites across the country (and perhaps world), which requires their representatives to continuously adapt their method of communicating and adjust their expectations depending on the local culture and institutional politics involved at each site. This is no easy feat and I commend those of you in this role for your flexibility and commitment to compliant research conduct.
On the flip side, research personnel at medical centers where externally sponsored clinical trials are conducted must manage multiple relationships with each of their external sponsors on a variety of clinical trial protocols. The variations between sponsor/CROs can be surprising at best and frustrating at worst. Sponsor X tells you the case report form worksheets can be used as source documentation. Sponsor Y reprimands you for writing a source note in the footer of the case report form. How do you keep all the requirements straight?
Below I will outline some recommendations for developing and sustaining sponsor-site rapport. Ultimately, we must recognize that we have an equal stake in the success of a trial and are jointly responsibility for clinical trial management and compliance.
Recommendations to Sites
- If sponsors make a request (e.g., please fax in a copy of the screening log every month; I need to visit the pharmacy at every site monitoring visit, etc.) it is ok to assess the appropriateness of the request before responding. That being said, the majority of time you should comply with the sponsor/CRO’s request. If something seems out of the ordinary or significantly increases your workload, run the request by your supervisor or central research support office. If the sponsor says it is a policy of theirs, request a copy of the policy for your files.
- Keep all communication professional and polite. You are busy and overworked. Your investigator(s) may not always treat you with the utmost respect. I totally get it. However, you are a representative of the medical center where you work. The sponsor/CRO are in many ways, your customers. The ways in which you choose to interact and communicate with external vendors has a significant impact on their decision to work with your institution/company. Recognizing your role in the success or failure of this relationship is vital. I can’t tell you how many times I have had to have the “be professional” talk with research staff. It seems so obvious but is often undervalued.
- The quicker you identify the ways in which this particular protocol and sponsor differ from your other projects and sponsors, the more successful you will be. These nuances are the things that will make or break your ability to successfully manage the clinical trial. It will also make you look like a rock star when you kindly remind your PI that the SAE you just discussed for protocol X must be submitted to the sponsor via the electronic reporting system within 24 hours unlike protocol Y requirement that SAEs be sent via facsimile. Being a quick learner who pays attention to details will also make you a desirable employee and open doors for future growth opportunities.
- Use your local resources to your benefit. Every medical center has a compliance office, human resources department, and a chain of reporting that you should follow if an issue occurs. Understanding the reporting relationship in your organization can be tricky but will be worth the time invested in learning it. Unfortunately, the reality is that there may be an incident that you need to discuss with someone other than your investigator. It could be a concern over the lack of coordination between departments where your research subject needs to be seen, or an error in the medical record that you discovered while completing case report forms. These types of operational issues are best reported to centralized offices that have the ability to address systemic issues. You aren’t alone in the management of your clinical trial(s). Finding your team of support people will significantly improve your ability to manage your trial portfolio and will likely earn you kudos for taking the initiative to get to know your organization.
Recommendations to Sponsors
- Identify your point person early on and determine their preferred method of communication. You can appreciate how busy site coordinators/nurses are and I know you do your best not to inundate them with requests. It is always helpful to know whether your particular coordinator/nurse likes to get phone calls, emails, or text pages. Respecting their personal preferences will go a long way in encouraging a good working relationship between you and the site.
- If you are working with a clinical research coordinator (CRC), obtain the contact information for their direct supervisor. Ideally this information would be obtained during a site initiation in a non-hostile manner. In academic medical centers, this should be a section or department manager or a supervisor in a central research support office. Investigators are not the best personnel managers and may not respond to future concerns you may have with the CRC. These types of issues are better served by elevating them to a direct supervisor or department administrator.
- Know the research support offices at each institution where you are working. I cannot stress this enough. If the central research support office doesn’t know there is an issue with an individual CRC, concerns over PI oversight, repeated noncompliance, or inadequate response to sponsor requests, there is no way for us to address the issue. Centralized research offices are often the best suited to take care of many issues you may be observing. We know the faculty, have relationships with research personnel, and can get things moving if a bottle stop has emerged. Call us or ask the coordinator/nurse to put you in touch with us. We are invested in the site-sponsor relationship and want it to succeed.
- Request a copy of research standard operating procedures and policies at each site. This will assist you in learning the local expectations for research conduct and help you do things like get access to the electronic medical record, learn the process for registering at the front hospital desk, obtain pharmacy monitoring hours and availability, etc. As a bonus, requesting these from your coordinator/nurse will also trigger them to refresh their memory about local SOPs and policies. There may be circumstances in which you are told you cannot receive a copy of local SOPs. In these cases, ask for a copy of tools or tip sheets designed for outside vendors.
Please share your thoughts on my recommendations.
Photo Credit:International Monetary Fund