Set up a meeting with Jerome Ritz, MD and Allison Andersen.
Provide a copy of the Draft protocol and lab manual, when available, to Jerome Ritz, MD and Allison Andersen.
Provide CRC, RN or other personnel’s contact information for the new protocol to Allison Andersen.
The CRC will need to open an IS ticket for the ‘DFCI RIO/Open Specimen Team’ to create a template in Open Specimen for a new protocol, after the CRC has complete the "New Protocol Design Template" found at wiki.dfci.harvard.edu:8443/openspecimen/new-protocol-template
New EPIC codes may need to be set-up for blood collections. This needs 2 months turnaround time. Check your blood collection requirements with Allison for current codes available.
NOTE: CRC must complete the template one month prior to the protocol becoming active. Once the template is prepared by the CRC, Allison can review it and help with any questions prior to submitting to the DFCI RIO/Open Team. The template will be placed in the Test environment for verification. Once approved by the CRC and Allison it will be moved to Production by the DFCI RIO/Open Team.
Information needed for template:
Protocol number and name.
Principal Investigator’s name.
Sites where samples will be collected.
Time points for samples being banked at the Pasquarello Tissue Bank, as listed in the Protocol.
Sample types being collected at each time point (i.e. Peripheral blood-EDTA tubes, Peripheral blood-Heparin tubes, skin biopsy, bone marrow, saliva, etc.).
Maximum volume of each sample type being collected at each time point.
Diagnoses.
What is being banked (i.e. PBMC, BMMC, plasma, pellets, granulocytes, etc.).
Is there a set number of aliquots request? (i.e. 2 vials of plasma of 1 cc each).
How do the vials banked need to be labeled.
Participant Protocol ID (PPI) to be determined. MRN, ONC ID or Study ID# depending on site of collection and requirements of labeling.