Over the last few months, members of the MiTy team have conducted a series of monitoring visits across Canada, and continue to be impressed by the level of dedication shown by both coordinators and investigators to ensuring the success of MiTy. We have seen many study staff go above and beyond their job descriptions, and we appreciate of all your hard work.
The following are examples of ‘best practice’ processes that we have encountered that have proven to enhance the conduct of the trial:
Qualified Investigator (QI) Oversight
• Lab value reports for prenatal visits are printed in order for the QI to initial, date, and assess clinical significance. These reports are filed in the patient research folder, and are a great example of documentation of QI oversight.
• Many have implemented the templates and worksheets provided in the Manual of Procedures. This is an easy way to ensure QI oversight is documented, and also ensures that we are complying with observations made previously during our Health Canada inspection.
• Post it notes or paper notes of values taken at the visits (i.e., insulin doses, blood pressure, weight) are dated, initialed, and filed in patient research folders. This ensures source documentation is easily accessible, and easily stored for the 25 year record retention period.
• Copies of the ultrasound reports that are used to verify gestational age prior to enrolment are de-identified and filed in patient research folders. While the copy is not considered the ‘source,’ it still enables us to easily locate the source to verify the eligibility criteria during our monitoring visit.