If you become aware that a study participant is deceased, notify the Trial Coordinator at Vanderbilt right away so that the patient can be appropriately withdrawn from the study and the death can be evaluated as a potential SAE (see J1 below).
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.
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.
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 [...]
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 [...]