STUDY INITIATION CHECKLIST

STUDY TITLE
PROTOCOL NUMBER
SITE, SITE NUMBER
SPONSOR NAME
PRINCIPAL INVESTIGATOR NAME
MONITOR NAME
DATE
METHOD OF VISIT	☐ On-Site ☐ Teleconference ☐ Other, specify:

List personnel in attendance from site, below. Attach attendance sheet.

NAME, TITLE	ROLE

Verify each document or activity required below. Attach any supporting documentation.

NO.	DOCUMENT OR ACTIVITY (DISCUSSED/VERIFIED)	YES	NO	N/A	COMMENTS
1	Staff CVs signed/dated	☐	☐	☐
2	Staff trained on protocol	☐	☐	☐
3	Staff read investigator brochure for product	☐	☐	☐
4	Check required number of forms delivered to site (i.e. consent forms, case forms).	☐	☐	☐
5	Sponsor and site have agreed to study contract and budget.	☐	☐	☐
6	Indemnity/insurance completed for site.	☐	☐	☐
7	EC/IRB approval granted for study.	☐	☐	☐
8	Staffing allocation complete.	☐	☐	☐
9	Specific staff responsibilities discussed with staff	☐	☐	☐
10	Staff trained in GCP.	☐	☐	☐
11	Required facilities are available/functional.	☐	☐	☐
12	Investigational product stored appropriately.	☐	☐	☐
13	Materials/equipment for study available/received.	☐	☐	☐
14	Investigator’s file prepared	☐	☐	☐
15	Final contract and budget signed and filed.	☐	☐	☐
16	Interactive Voice Response Systems (IVRS) available (if applicable)	☐	☐	☐
17	e-case forms available (if applicable)	☐	☐	☐
18	Drug shipment received (if applicable)	☐	☐	☐
19	Other supplies received (if applicable)	☐	☐	☐

Name of Monitor (Print)
Monitor Signature	Date

Name of Principal Investigator (Print)
Principal Investigator Signature	Date

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