Coordinator Training

Tips for Coordinators:

• Please submit all documents electronically, as it makes it easier for us to make revisions for you, especially on the ICF. The only original form we need is the TGH Study Application with the PI’s signature.

• Please remember to submit copies of all IRB documentation to the OCR. This includes the initial approval letter and approved ICF, any continuing review or modification approvals, and final closure letters.

• Please remember when you (or your staff) are scheduling a patient for an outpatient research procedure here at TGH, to inform TGH that the patient is on a research study. The enrollment notifications to OCR are a back-up to ensure that we detect all research patients, but the account should already be flagged as research as soon as the patient is scheduled.

• Please submit the Lab Manual to OCR, along with your study documents, for any studies involving use of TGH laboratory.

• For drug studies, please also submit a copy of the protocol and Investigator Brochure to the Research Pharmacy. They can also review your Drug Data sheets prior to submission to OCR. They have established a new email address, researchpharmacy@tgh.org, for all pharmacy correspondence. This automatically goes to both the Research Pharmacist and the Drug Service Tech.

• For device studies, please remember to also submit the Investigator Brochure for Devices to the OCR, which includes all prior research and safety analysis of the product.