WHAT is the Staff Signature Log?
The Staff Signature Log is a list of all key personnel, their signature and initials.
Includes the following information (as seen in our templates)
Staff’s printed name
Initials
Start and end dates
Staff’s study title/role (e.g. PI, Research Nurse)
Delegated study tasks
WHEN is a Staff Signature Log Required?
Sponsors may require investigators to maintain a Staff Signature Log, in which case sponsors should specify what information to capture, or provide the log prior to study start.
The log is recommended for all studies to assist in conducting the study in a more efficient and organized manner.
WHY would you need a Staff Signature Log?
A Staff Signature Log can easily provide an updated reference of research staff, past and present which can be especially helpful for studies that are long in duration, have large staff number, and/or have had staff turnover during the study.
Capturing the original signature and initials of all staff members prior to start on the study, may help authenticate or verify data entry if questioned, based on time frame and handwriting/signature.
HOW do you use it?
Create a log that includes all the information that the research staff agrees will be useful throughout the study. Templates are provided. Complete the log prior to study start, including only those who are listed on the Lifespan IRB approved personnel list. Update with any staff changes approved by the IRB through amendments and continuing reviews.
WHERE do you put it?
If a sponsor provides the Staff Signature Log, file as instructed. Otherwise, the log may be filed in the Regulatory Binder in a location easily accessible and available for the research staff to reference and update as needed.
May 2010
PAGE 2 TO BRANCH MANAGERS AND STAFF FROM
PROFESSIONAL STAFF CSOPERT CONTRACT VENDOR SEARCH &
RECORD OF OBSERVATION OF TEACHING FOR ALL STAFF
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