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 ID: 539446
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Transition to email IRB submissions
Informational session* To play The presentation, click on this icon On the Status Bar belowSlide2
Yale IRBs
HIC I (paper submissions only)HIC II (Coeus, paper)HIC III (Coeus, paper)HIC IV (paper, Coeus)
HSC (email only)3 administrative assistants for HIC1 administrative assistant for HSC
Goal – eliminate paper submissions by August 1Slide3
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 OncologyTherapeutic RadiologyHIC II (Jennifer Reese, Stacey Scirocco)
DermatologyImmunobiologyOphthalmology & Visual Science
PathologyPsychiatryYale School of Nursing
Diagnostic RadiologyMechanical/Chemical EngineeringJB Pierce (for PIs with appointments also in Psychiatry)Slide4
Division of Departments
HIC III(Michele Antisdel, Ellen Bedard)AnesthesiologyChild Study CenterInternal MedicineObstetrics and GynecologyOrthopedics and Rehabilitation
PharmacologyJB Pierce – OB/GYN Comparative MedicinePhysiology
HIC IV(Amy Blakeslee, Donna Lacivita)School of Public Health
Emergency MedicineGeneticsLaboratory Medicine
Neurology
Neurobiology
Neurosurgery
Pediatrics
Surgery
Haskins
Urology, Cell BiologySlide5
Transition Dates
HIC III – Monday, April 6HIC IV - Monday, May 4HIC I – Monday, June 1HIC II – Monday, July 6Slide6
Process
1. Submission comes into emailhic.submissions@yale.eduAdministrative assistant checks:
PI’s training/COISubmission Cover SheetAppropriate SignaturesZip file
Automatic Receipt SentSlide7
Admin Actions
RejectionYou will get an email that the submission was rejected and reasons why.Resubmit the entire submission to hic.submissions@yale.eduProcess and Pass to Regulatory AnalystYou will NOT get an email 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 email.Slide8
Triage – RA’s actions
Regulatory Analyst checks for completeness of the submission e.g. are amendment changes described properly in the amendment request form? RejectionYou will get an email explaining why the submission is rejected and what steps to take.Triage to ReviewSubmission is placed in queue awaiting review (expedited or full committee).Slide9
Review and Approval
The submission follows a regular review process (expedited or full board) When revisions are needed during/after review, you will receive email from your regulatory analyst (‘SMR’ or revisions to regulatory review) When approved, you will receive an email from your regulatory analyst with approval letter and approved documentsSlide10
Submission Instructions
All protocol related documents must be emailed to HIC.submissions@yale.edu with the subject of the email as follows: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) Slide11
Instructions
All documents should be in a zipped fileAlways include a completed Submission Cover Sheethttp://www.yale.edu/hrpp/resources/docs/submissioncoversheet.docx
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.Slide12
Electronic signatures
NO typed signatures in WORDAcceptable forms:Electronic signature on PDF documents (Adobe) or WORD documents Scanned signature pagePI emailing the documents him/herself (not just being copied on the email) The above referenced methods are acceptable for the Department Chair’s signature on new submissions and other forms requiring the Department Chair’s signature. Slide13
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.Slide14
Points To Remember
Do not email submissions the regulatory analyst directly – use hic.submissions@yale.edu Finish paper submissions (e.g. if revisions were requested on a paper amendment) before switching to email30 days from the transition date before we stop accepting paper submissions for each teamSlide15
Questions?