Transition to IRB submissions INFORMATIONAL SESSION * TO PLAY THE PRESENTATION, CLICK ON THIS ICON ON THE STATUS BAR BELOW

Yale IRBs  HIC I (paper submissions only)  HIC II (Coeus, paper)  HIC III (Coeus, paper)  HIC IV (paper, Coeus)  HSC ( only)  3 administrative assistants for HIC  1 administrative assistant for HSC  Goal – eliminate paper submissions by August 1

Division of Departments HIC I (Dawn Pedevillano, Christine Earley)  Comprehensive Cancer Center including: Adult Oncology, Bone Marrow Transplant, Pediatric Oncology, Hematology/Oncology, Medical Oncology, Surgical Oncology  Therapeutic Radiology HIC II (Jennifer Reese, Stacey Scirocco)  Dermatology  Immunobiology  Ophthalmology & Visual Science  Pathology  Psychiatry  Yale School of Nursing  Diagnostic Radiology  Mechanical/Chemical Engineering  JB Pierce (for PIs with appointments also in Psychiatry)

Division of Departments HIC III (Michele Antisdel, Ellen Bedard)  Anesthesiology  Child Study Center  Internal Medicine  Obstetrics and Gynecology  Orthopedics and Rehabilitation  Pharmacology  JB Pierce – OB/GYN  Comparative Medicine  Physiology HIC IV (Amy Blakeslee, Donna Lacivita)  School of Public Health  Emergency Medicine  Genetics  Laboratory Medicine  Neurology  Neurobiology  Neurosurgery  Pediatrics  Surgery  Haskins  Urology, Cell Biology

Transition Dates  HIC III – Monday, April 6  HIC IV - Monday, May 4  HIC I – Monday, June 1  HIC II – Monday, July 6

Process 1. Submission comes into Administrative assistant checks: PI’s training/COI Submission Cover Sheet Appropriate Signatures Zip file Automatic Receipt Sent

Admin Actions Rejection You will get an that the submission was rejected and reasons why. Resubmit the entire submission to Process and Pass to Regulatory Analyst You will NOT get an if the submission is passed to RA for triage. If it’s a submission of a new protocol (initial protocol submission), you will get the HIC number via .

Triage – RA’s actions Regulatory Analyst checks for completeness of the submission e.g. are amendment changes described properly in the amendment request form? Rejection You will get an explaining why the submission is rejected and what steps to take. Triage to Review Submission is placed in queue awaiting review (expedited or full committee).

Review and Approval  The submission follows a regular review process (expedited or full board)  When revisions are needed during/after review, you will receive from your regulatory analyst (‘SMR’ or revisions to regulatory review)  When approved, you will receive an from your regulatory analyst with approval letter and approved documents

Submission Instructions  All protocol related documents must be ed to with the subject of the as ◦Request for initial review: ‘Initial Protocol Submission for xxxx (name of the PI)’ ◦Request for renewal: ‘Renewal for xxxx (protocol number), xxxx (name of the PI)’ ◦Request for amendment: ‘Amendment to xxxx (protocol number), xxx (name of the PI)’ ◦Revisions requested by Committee, chair or vice-chair, or a regulatory analyst: ‘Revisions to xxxx (type of submission - e.g., renewal) for xxxx (protocol number), xxx (name of PI)’ ◦Other submissions - e.g., deviation reports, SAEs, approval from other Committees, etc.: FYI for xxx (protocol number), xxxx (name of the PI)

Instructions  All documents should be in a zipped file  Always include a completed Submission Cover Sheet  Protocols, applications and consent documents must be submitted in WORD.  For amendments, amended versions of documents must show tracked changes. Do not submit both tracked changes and clean versions of the same forms.

Electronic signatures  NO typed signatures in WORD Acceptable forms: Electronic signature on PDF documents (Adobe) or WORD documents Scanned signature page PI ing the documents him/herself (not just being copied on the ) The above referenced methods are acceptable for the Department Chair’s signature on new submissions and other forms requiring the Department Chair’s signature.

Adobe Signatures If you are using electronic signatures or a scanned handwritten signature, make sure to also send WORD version of the document without the signature.

Points To Remember  Do not submissions the regulatory analyst directly – use  Finish paper submissions (e.g. if revisions were requested on a paper amendment) before switching to  30 days from the transition date before we stop accepting paper submissions for each team

Questions?