Protocol deviations and violations should be reported as soon as possible to the Trial Coordinator, who will document the occurrence and report it to the IRB as appropriate. Local IRB reporting requirement may also apply.
A protocol violation is an accidental or unintentional change to the IRB-approved protocol procedures without prior sponsor and IRB approval. Violations, as opposed to simply deviations, generally affect the subject’s rights, safety, welfare, and/or the integrity of the resultant data. Examples of protocol violations include (not an exhaustive list): Informed consent obtained after the initiation [...]
A protocol deviation is an incident involving noncompliance with the protocol, but one that typically does not have a significant effect on the subject’s rights, safety, welfare, and/or the integrity of the resultant data. Deviations may result from the action of the participant, investigator, or staff. Examples of protocol deviations include (not an exhaustive list): [...]
It is important that serious adverse events (SAEs), adverse events (AEs), or other unanticipated problems be reported immediately to both the Trial PI (Nitin Jain) & Trial Coordinator (Helen Koudelková). Information about Serious Adverse Events (SAEs) and Adverse Events (AEs) will be systematically collected via patient questionnaires. However, should study personnel become aware of such [...]
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participant is deceased, notify the Trial Coordinator at Vanderbilt right away so that the patient can be appropriately withdrawn from the study and the death can be evaluated as a potential SAE (see J1 below).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 [...]
You will only use REDCap again to update surgery dates and to upload forms to Source Documents. You will not use any new instruments at later time points.