November 2024 SOCRA Source Journal - Journal - Page 42
Documentation of Training
As just discussed, if staff are
to be delegated tasks, they
must be appropriately trained.
Training and its documentation
are supported by both FDA
regulations and GCP guidelines.
They emphasize that staff
members must be quali昀椀ed for
their study tasks by education,
training and experience.
TABLE 1
The Delegation of Authority Log
Per FDA regulations:
•
21 CFR 312.53(a):
“A sponsor shall select only
investigators quali昀椀ed by
training and experience
as appropriate experts to
investigate the drug.”
•
21 CFR 312.53(c)(2):
“A curriculum vitae or other
statement of quali昀椀cations
of the investigator showing
the education, training, and
experience that quali昀椀es the
investigator as an expert in
the clinical investigation of
the drug for the use under
investigation.”
•
21 CFR 812.43(a):
“A sponsor shall select
investigators quali昀椀ed by
training and experience to
investigate the device.”
And GCP guidelines:
•
•
42
2.8 The Principles of ICHGCP: “Each individual
involved in conducting a
trial should be quali昀椀ed by
education, training, and
experience to perform his or
her respective task(s).”
4.1.1 Investigator’s Quali昀椀cations and Agreements:
“The investigator(s) should
be quali昀椀ed by education,
training, and experience to
assume responsibility for
the proper conduct of the
trial, should meet all the
quali昀椀cations speci昀椀ed by
the applicable regulatory
requirement(s)….”
•
•
Study personnel and roles to include:
o Principal Investigator
o Sub-Investigators
o Research nurses
o Coordinators (data and regulatory)
o Primary research pharmacist
o Medical monitor
•
Responsibilities:
o Ensure responsibilities are assigned:
- Accurately
- Appropriately
- Clearly
o If responsibilities change:
- Enter the stop date for the initial entry
- Create a new entry
•
Review often and make edits in a timely manner
•
Include start and stop dates:
o Start date should precede performance of any
study-related tasks
o Start date should be after training is complete and
staff member is knowledgeable about role
o Start date should not precede IRB approval
o Stop date should be added when role(s)/task(s) change
or when staff member is not serving in role and no further
study-related activity is planned
•
Staff signatures and initials:
o Handwritten signatures or initials allow validation of
documents
o If electronic log is used, create individual signature pages
to capture signature/initials
o Clinical investigator signature/initials con昀椀rm approval
and oversight of delegation
5.6.1 Investigator
Selection: “The sponsor is
responsible for selecting the
investigator(s)/institution(s).
Each investigator should
be quali昀椀ed by training and
experience…”
This training should be
documented, either on overall
or individual logs (see Diagrams
4 and 5 on next page) and 昀椀led
in regulatory binders.
SOCRA SOURCE © November 2024
Eligibility Checklist
The Eligibility Checklist is another
essential component of research
documentation that all monitors
and auditors will review.
Eligibility criterion ensure that
subject population is uniform
(e.g. age, type/stage of disease,
general health), risks are
minimized to persons who might
be harmed by the research and
昀椀nally, that the results of the
