What should I do if a patient tells me they want to withdraw from the study?

Contact the Trial Coordinator at Vanderbilt and relay the information about the patient’s request, including the date and manner (phone, email, etc.) in which the request was made. Attach  any supporting documentation from the patient, such as an email, letter, etc. (if available). Coordinating Center staff at Vanderbilt will take care of withdrawing the patient.

What kind of patient information can I share over email?

When referencing a patient in an email, always use the Study ID number instead of the patient’s name. You can also include general information like appointment date, appointment time, and patient initials to clarify which patient you are discussing. Do not use names, birthdates, MRNs, or social security numbers.

When & how do I send the patient’s MRI to the coordinating center?

The patient’s MRI and X-ray images (if applicable) should be burned onto a CD and mailed to the coordinating center within several weeks after randomization. MRI discs should be stored in a locked file cabinet and sent in batches via FedEx (per the shipping instructions provided) to the coordinating center once a month. The CD [...]

What should be done with source documents after enrollment?

All pages of paper versions of case report forms (CRFs) and informed consent documents must be scanned and uploaded to the Source Documents instrument in REDCap after enrollment. Keep these paper forms stored on site in a folder labeled with the patient’s Study ID in a secure location (locked file cabinet) only accessible to research [...]

What are the RA Notes sections of each form for?

These are areas for you record any relevant information not already captured in the form that would be helpful for coordinating center staff or someone looking at the record later on to know (e.g., if the patient cancelled their original appointment and has rescheduled for another date, or the patient is leaving on vacation and [...]

Which REDCap instruments will the site RA complete and which will Vanderbilt complete at enrollment/ baseline?

The RA should complete the following REDCap instruments during screening/enrollment: Screening Log  Informed Consent Eligibility Patient Study Info Overview Randomization Module (once patient is ready to be randomized), and Source Documents (upload scanned copies of paper documents) Physical Exam Form Part B (if RA is using the electronic version) Research staff at Vanderbilt will complete [...]

Do I need to do anything regarding the Physical Therapy Report Forms?

No. Coordinating Center staff will be responsible for following up with patients to get contact information for their treating physical therapist and will send out Physical Therapy Report Forms via email (using a REDCap survey) to treating physical therapists at the appropriate time points.

What methods can the MD use to complete the Surgery Report Form?

There are 3 ways to complete the Surgery Report Form: On Paper – The site RA provides the MD a paper copy on the day of surgery that the MD completes and returns within 1 week. The site RA then uploads the completed form to REDCap. Electronically in clinic – The site RA pulls up [...]

Go to Top