Tell Me About A Time When Flashcards
TMF reconciliation for FDA inspection prep
Situation/Task
- 1st responsibility = ensure TMF = inspection ready.
- TMF & material filed entirely new. No recent reconciliations so lots of gaps
Actions
- Lead mtgs revising outdated study-specif content lists (500 lines - overlap and difs), work w/ DSQ, CRO to align on filing specs. Google searching and asking Qs to understand TMF content
- Work w/ DevSci Qual team to identify target sections in comp review. Internally locate missing documentation and hold mtgs w/ study leads to summarize sections/ identify gaps. Work x-func to hold other teams accountable (DM, CSC, CLS and CRO)
Results
Healthier TMFs and accurate/consistent content lists for all groups to reference. Regular TMF reviews.
HEAL-EEG chunks missing
Situation/Task: I review and mark EEGs for completeness. Sites send some EEGs with large chunks of time missing (i.e. pruned)
Action: Bring detailed info about how many hrs per subject to supervisor, figure out what’s usable vs not usable. Summarize the issue to CRC and have them investigate if there are unpruned recordings available.
Resolution: we got some new full studies from some sites. Others excluded from study. Standard became > 1 hr can’t be missing. Emphasize to CRCs over every call to prevent then saving and sending the incomplete recordings. Prioritize looking at detail and quality as a whole
MedPoint Example
Situation/Task: Uploaded PCL for PI sign-off following instruction sheet & not received
Action: Immediately escalated issue to vendor & troubleshoot on calls where I can show process. PM says should have worked and F/U w/ programmers. Comes back with new instructions (not intuitive to someone new) so I manage vendor to have instrucs updated & instruction sheet for sites sign- off. Also clearly describe issue & my actions to supervisor.
Res: Sites receive and are able to sign off in timely manner. Process smoother moving forward and also prevent delay in SUSAR signoff b/c sites familiar w/ new process
Supervisor asks you to complete task you think is not necessary
Sending digital EEG reports along with EEG recordings when they are already uploaded to CRF. Some end up not sending them at all. I tell her its redundant and instead of having them repeat the work lets remove this step. She agrees.
Site contact lists example
Situation/Task:
- Manage mass site communications on study updates and important information requiring immediate attention (eg: PCLs, add’l treatment guidance letters, program updates, regulatory agency updates)
- 2 CROs w/ different processes for site contact lists – 6 separate contact lists needed for 1 cross-program communication stored in different systems
- 1 CRO often had outdated contacts
Action:
- Manage that CRO to provide new contact list for essential site communications – main SC and PI, provide whenever updates made
- New system where all site contact lists stored in one location and updated on weekly basis
- Also add communications in Investigator Portal so they’re stored in a central location for site
Res:
- Contacts are up-to-date and communication from sponsor is consistent and received and anyone can easily access the contact info
Patient facing informational booklets
Situation/Task: Print patient facing material for sites following same process w/ chosen vendor. Begin process although since ordering in batches instead of bulk, expensive.
Action: Bring quotes back to study lead and suggest we check what it would cost to have CRO print. Agrees & I work w/ CRO to quote for comparable quality
Res: Few $1000s savings
Communication issue
Legal issue with participant – ultimately reiterated this study is voluntary, you have right to decline and it will have no effect on your child’s care. If you are later interested in participating please give me a call back
Success: GENE study
Took full ownership of this study. Study startup and seeing project through in 6 months. Was initially questioning the feasibility of recruiting families for genetic study where both parents and child undergo genetic testing. Recruited goal of 20 families and managed procurement of saliva samples in processing lab. Rewarding to see the project through and to build cohort.
Mistake that I learned from: HEAL-EEG Invoicing
Situation: was on 2 wk vacay then invoicing deadline once I’m back. Figured all financial teams would abide by contract and invoice in time. Also I notified everyone about completed milestones but some financial teams miscalculated and did not have full invoice in 1 day before deadline…
Action: sent out quick email reminding and highlighting who had funds left over. CRCs reach out confused, I deal site by site by looping in my financial team and theirs to pinpoint discrepancies.
Resolution: everyone was able to invoice for the period and I added a section to SOP to send follow-up reminder 2 weeks before invoice due. Learn need to have foresight and be proactive to ensure things are moving along in entire project, even realms where you’re less involved. Also clarify all responsibilities beforehand.
CT.gov Process and SOP change
Situation/Task:
- New SOP/WI issued for CT.gov processes that requires changes to our study listings
- Missing detail on when to add site to locations list
Action:
- I bring discussion internally and there’s back and forth. Ultimately bring questions to the SOP developer and get clarification
- Review all CT.gov listings and ensure compliance w/ new SOP/WI
Res: detail added to SOP for alignment across programs
TMF doc filing issues CRO
Situation/Task: CRO filing things incorrectly escalated by DSQ team to me
Action: Bring issue to CRO and suggest training
Res: Productive training and good filing outcomes/less issues
Discrepancies in Investigator documentation found (CSR)
Situation/Task: Collating info for CRS appendix 16 / FDF tracking. Find discrepancies for a couple PIs when looking at dates DoA log, FDF, CVs were signed. Out of compliance?
Action: Manage CRO to gather add’l info on discrepancies from sites - provide feedback & I work w/ study lead to come up with required actions from CRO
Result: NTF justifying delays in signature, add’l missing documentation filed to close gaps
