Study Start-Up Checklist

Study Start-Up Checklist

Study Start-Up Checklist

Instructions:

·  This form MUST be completed prior to any subject enrollment or data collection

·  Submit a copy to the Advocate Center for Pediatric Research (ACPR), c/o: Cheryl Lefaiver, , Oak Lawn Room 2179H, or fax 708-684-3227

·  If you have questions about this form, please contact your ACPR study coordinator or Sandy Maki at , 21-7570

Protocol Title:

IRB Number:

Principal Investigator:

Study Coordinator(s) (SC) (if applicable):

/ Yes / No / NA / Comments (address any “no” answers) /
INITIAL STUDY REVIEW
1.  Have you received your IRB approval letter? (Note: this will come interoffice mail and will include the dates of approval and expiration)
2.  Have you received the approved, stamped parent permission/consent and assent forms from the IRB (if applicable)?
3.  Do you have a HIPPA authorization form for subjects to sign in conjunction with the parent permission/consent and assent forms (if applicable)?
4.  Have you registered the study in clinicaltrials.gov (if applicable)?
5.  Have you made ANY changes to the approved protocol (e.g. recruitment plan, subject eligibility, sampling, methods, data collection)? Note: If any changes are made, submit a IRB modification HRP-213
STUDY FORMS and STORAGE
6.  Do you have your eligibility checklist finalized and prepared for use (if applicable)?
7.  Do you have your data collection forms finalized and prepared for use?
8.  Have the data collection forms been approved by the IRB?
9.  Will you be using a flyer or letter to advertise or recruit subjects for your study?
10.  Have you received approval from the IRB to use these methods for subject recruitment?
11.  Have you made ANY changes to the approved data collection forms or recruitment documents (e.g. flyer, letter)? Note: If any changes are made, submit an IRB modification HRP-213.
12.  Is your study binder (i.e. regulatory, billing, patient document storage) prepared?
13.  Does your binder include a section for IRB correspondence? Note: Keep copies of all communication with IRB.
14.  Does your binder include a section(s) for other correspondence (e.g. Sponsor, FDA, Grant agency)?
15.  Have you prepared appropriate locked storage for study materials, documents and informed consents?
16.  Do you have a secure password protected data entry file and available storage on a password protected computer?
17.  Are study supplies (e.g. investigational drugs or devices, lab kits) available and ready for use?
DELEGATION OF RESEARCH TASKS
18.  Have you completed a site Delegation of Authority & Signature Log to outline the research team member responsibilities? (Keep the original signed log in your study binder)
19.  Have you trained the research team to fulfill their delegated study responsibilities?
20.  Do you have a process in place to address and report adverse events (if applicable)?
WHO WILL PREPARE: / PI / SC / OTHER (EXPLAIN)
21.  IRB Continuing Review Form (annual report) (HRP-212)
22.  IRB Modification Form(s) (HRP-213)
23.  IRB Reportable New Information Form (HRP-214)
24.  Adverse Event Reports for submission to the IRB (HRP-214) and the Sponsor (if applicable)
STUDY TIMELINE
Comments
Start Date: /
Anticipated Accrual Rate: / # subjects/week / # subjects/month
End Date: /

Signatures

Principal Investigator: ______Date: ___/___/____

Study Coordinator (if applicable) ______Date: ___/___/____

·  This form MUST be completed prior to any subject enrollment or data collection

·  Submit a copy to the Advocate Center for Pediatric Research (ACPR), c/o: Cheryl Lefaiver, , Oak Lawn Room 2179H, or fax 708-684-3227

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