[Q&A] Regulatory Affairs, Questions Answered
The world’s first ever clinical trial was conducted by King Nebuchadnezzar in 562BCE and is recorded in the Book of Daniel. The king hypothesized that people who only eat meat and wine will be in better physical condition then those who only eat legumes and water. After 10 days, the vegetarian group proved to be better nourished then the meat eaters. Research has come a long way since then, and now has standardized rules to protect the safety of patients and the study themselves. In our recent webinar, Kasi Bettencourt reviewed Regulatory Essentials needed to run ethical, yet successful, studies at your research institution.
Most trials follow the same type of format when submitting your initial regulatory packet for a new study. After you complete a couple of submissions you will be able to do it in your sleep.
Standardization is key: Utilize your site’s SOPs and CRO guidelines on initial Submission.
Do you have experience with Electronic Regulatory MS?
Currently we utilize a CTMS system (Realtime) which allows use to electronically upload all of our submission documents then submit to users (like PI and SC) for electronic signatures. These documents are then stored within the system under the specific trial they correlate to. Once, documents are final we can send the pdf version to the sponsor/CRO reg specialist or we can grant that specialist access to our CTMS system. If access is granted you can set parameters of what that user can access. This includes upkeep of regulatory documents and CRA monitoring of your sites electronic TMF.
Should all back up staff be on the 1572?
We wouldn’t recommend adding back up staff, only key staff members. For example, if you have a backup phlebotomist I wouldn’t add him/her to the FDA 1572 form because that person might change frequently. This person will be documented on the DOA Log – CV to reflect site- and lastly protocol training on either a training log or a memo to file.
What are most efficient procedures for managing TMF
We recommend setting a day a week to manage your TMF binders. On a daily basis you will receive timeline updates, training documents, manuals, etc…. most coordinators do not have time to review-print-re-review with staff- then file in the TMF. If you review and print then place into a specific study folder within your SC office, you can then set a day like Fridays grab that folder and update the TMF binders. We recommend you touch on each binder tab to ensure all logs and sections are up to date. Also a good idea to review the binder again the day before your next monitoring visit.
BTC Network will launch training courses for all research site professionals, providing guidance on how to complete a trial from beginning to end! These modules will also contain scenarios and obstacles that sites face every day.
- PHASE ONE courses will include information regarding regulatory guidance and coordination of trials.
- PHASE TWO courses will provide specific training on patient recruitment, including the pre-screening process, chart review, updating CTMS, and campaign proposals. Courses will discuss how to maximize ad dollars, negotiate marketing budgets, etc.
- PHASE THREE courses will be focused on business difficulties sites encounter. This includes business development and pipeline management as well as financial management, including contracts & budgets, receivable management, and accounting. The courses will also review key performance indicators for sites – what to measure, how to measure and how to maximize site capabilities.
If you’d like to watch the webinar on-demand, click the image below:
To learn more about our upcoming learning courses, email firstname.lastname@example.org.
About BTC Network
BTC Network is North America’s leading clinical research group. Based just outside of Boston, Massachusetts, our network includes more than 50 multi-therapeutic sites. All BTC research sites collaborate with or are part of private practices, giving us access to over 100,000 patients.