Number 5

Initiation
Visits
What does ICH GCP say?
5.23: For multi-centre trials, the
sponsor should ensure that
5.23.4: All investigators are
given instructions on following
the protocol, on complying with
a uniform set of standards for
the assessment of clinical and
laboratory findings, and on
completing the CRFs.
5.23.5: Communication between
investigators is facilitated.

What is the purpose of an initiation visit?

How should I conduct the visit?

The purpose of an initiation visit is much the same

as for an investigator meeting. It ensures the
investigator and site staff are familiar with study
documentation, investigational medicinal product
(if applicable), administrative procedures and that
they are aware of the investigators responsibilities
regarding compliance with the clinical protocol
and the care of study subjects. The need for an
Initiation visit is sometimes removed by utilising
the investigator meeting to complete this process.

The meeting may take the form of an informal

presentation with time for discussion and
questions by the site staff.

What should I do prior to the meeting?

Investigator brochure

A mutually convenient meeting date should be

agreed with the site which ensures as many
members of the team are available to attend as
possible. Remember to contact other departments
that may be involved in certain procedures for the
study, as you will need either invite them to the
main initiation visit or allow time to visit them
while you are on site.

Use and maintenance of the Investigator Site

File. Previously unsigned agreements will be
obtained (CTA, FDA 1572, Financial Disclosures,
etc.)

A full agenda should be sent out to site prior to the

meeting.
All essential documents should be in place prior to,
or collected during, the meeting. All study supplies
should have been delivered to site prior to the
conduct of the meeting.

The following issues must be covered:

Study timelines
Clinical protocol requirements: objectives,
inclusion/exclusion criteria, study procedures,
visit schedules and reporting of protocol
violations

Responsibilities regarding the informed consent

process
Subject recruitment regarding agreed target and
procedures for identifying potential subjects
Safety reporting
Requirements regarding source data verification
and minimum medical record entries. A source
data verification agreement form may be
completed detailing where source data will be
found
CRF completion, study worksheets
Regulatory requirements

 The role of any special investigations or

procedures used during the course of the
clinical study, e.g. central labs
The role of other site personnel (research
nurse, SSCs, etc). A delegation of duties and
authorised signatories log will be completed by
all staff involved in the study. Any previously
uncollected CVs will be obtained
Procedures and responsibilities for delivery,
storage, dispensing, accountability and
collection of any IMPs (if applicable)
Training on IVRS (Interactive Voice Response
Systems) and/or eCRFs if applicable. Consider
whether training on these systems will be
delivered on discs, at the investigator meeting
or during the initiation. If delivered during the
initiation visit, ensure that all site staff are then
promptly provided with user ids and passwords.
(NB The PI should always receive training and
a password on such systems if in use, as they
take overall responsibility for the data entered
and this is often a common audit finding if
the investigator has been found never to have
accessed the system)
Timing and requirement for monitoring visits
Requirements for audit
Inspection of facilities for all departments
involved

A visit sign in log will be completed to record

who attended the meeting.
If there is insufficient time during the Initiation
Visit the following issues may, if necessary, be
covered at a later date with the appropriate site
staff:
Review of the CRF in detail. Specify expected
data entry points and ranges and highlight
acceptable completion and correction
procedures
Visits to pharmacy may be conducted nearer the
time of recruitment (i.e. upon the first patient
being screened if there is a few weeks between
screening and randomisation)
If unavailable during the initiation visit, a
visit should be scheduled as to other internal
or external facility involved in the study, e.g.
hospital or central labs, radiology, etc. Study
documentation relating to this/these will be
reviewed and evidence of calibration should be
discussed.

What should I do after the visit?

A site initiation report should be completed by the
CRA following the visit, which should be signed
by the CRA and signed off by the project manager.
You may also need to have sponsor review of the
report prior to finalisation, depending on the SOPs
for the study. Once finalised the original report
should be filed in the Trial Master File and a
copy filed in the investigator site file. A follow up
letter should be sent to the investigator thanking
them for their time and detailing any decisions or
issues covered. Copies should also be sent to all
appropriate site staff.