Signature / task delegation log
BUMC Clinical Research Study Regulatory Binder Tab Inserts Version 7/1/08
Study name:
Study PI:
Study ID #:
Signature/Task Delegation Log
This log has two purposes. First, it is a documentation of signatures and initials of all staff that collect and record study data so that study documentation attributed to specific staff
members may be verified. Second, it lists the study-related activities that the staff member may do, per delegation by the PI. Please ensure that all staff listed on this log are also
IRB-approved to do the task to which they are assigned (i.e. such as consenting participants) and that they are qualified by training, education, and license to do so (as in
administering medications, performing physical exams and assessments, assessing AE seriousness, grade, attribution, etc.)
Print Name
Degree(s)
1
Title (on
study)
Signature
Initials
Study tasks
(see below)
Start
date
End
date
Phone #/ e-
mail
PI
Initials/date
1
For those with clinical licenses, obtain documentation (photocopies) of current licensure. See Staff License/Certification Log.
PI Signature (at end of study only): __________________________________________________________ Date: ______________________________________
Study Task Codes
a. Obtain informed consent (IRB-approved)
b. Informed consent process
c. Obtain medical history
d. Perform physical exams
e. Performing physical assessments
f. Eligibility assessment
g. Drug administration
h. Drug dispensing
i. Drug receipt, accountability, returns,
descruction
j. AE assessment
k. CRF completion
l. CRF signature
m. Query completion
n. Safety monitoring
o. IRB submissions
p. Update/maintain IRB docs
q. Update/maintain regulatory docs
r. Obtain study measurements/collect data
s. Process sample specimens
t. Shipping hazardous materials (i.e. human
tissue specimens, dry ice, etc.)
u. Other:
v. Other:
w. Other:
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