10-12, 22-28

What is Routine Site Monitoring? What are the activities conducted by a CRA at the
site during the monitoring visit? 

Monitoring is defined as a process which is completed to manage the conduct of clinical trial
and that it is being conducted, documented and reported as per ICH-GCP guidelines, SOP’s
and procedure.

The purposes of routine monitoring visits (RMV) :

 To guarantee data quality by assessing the case report form (CRF) entries for
wholeness, correctness, legibility, and by authorizing CRF data against basis
documents.

 To guarantee the safety of subjects' rights by settling the being of properly signed
informed consent forms, settling written approval by the Institutional Review Board
or Independent Ethics Committee (IRB or IEC) for the study and appropriate
documents, settling continuing review, if appropriate, by the IRB/IEC, and
guaranteeing sufficient protection reporting.

 To guarantee that study lead obeys with ICH GCP guidelines and appropriate
regulations. This includes settling that all needed controlling documents in the study
file are current, confirming that new product is stored and accounted for correctly.

In few cases, such as studies that involving complex study drug administration, the first
monitoring visit may accord with the first patient’s therapy arrangement.

The frequency of following visits should be in agreement with that stated in the monitoring
plan. Usually, this frequency is associated with:

 Subject enrolment: Faster the subject enrolment more is essential to show the site and
it’ll require more visits.

 Degree of site obedience: If the investigator and site staff have a trouble in obeying
the protocol, additional visits are required.

 If a site has a advanced rate of adverse events, more frequent visits may necessary to
control the cause.

 Teaching the site team is important for the responsibility of the sponsor.

The frequency of the patient visit and the data made at every visit will make a direct impact
on the sponsor determination to visit within short intermissions.
Essentially, monitoring visits should be performed as frequently as specified in the protocol
and/or contract, and/or as often is as needed to ensure appropriate administration of the trial.

When the monitor reaches at site, he or she should meet with the site staff (mainly the CRC
or the Co-PI) mainly to review the availability. There are different ways the monitors usually
start their monitoring visit but ideally the monitor should start their day by discussing out
priority or urgent issues which need resolutions as soon as possible with the PI. Current
patient status at the site is discussed with the PI. In case the recruitment at the site is not as
decided during the earlier visits then the same is discussed with the PI and plan future
recruitment strategies with the PI. Request any items that are outstanding or pending
resolution since the last visit. Discuss regarding site personnel changes if any at the site. In
case there is a change or addition of a new site team member be sure that the new team
member is entered in the site responsibility log following which study and protocol related
training is arranged for the new member before the new site team member performs any
study related activity. In case the member is inducted in the team before the visit then all the
activities needs to be performed telephonically and then needs to be checked by the monitor
during the next monitoring visit. The Investigator can also train any new site team member
and document the same by providing a training certificate for the same before the new site
team member starts working on the study. Review the site for continued availability of the
required infrastructure for the conduct of the study at the site.

The monitor may begin the monitoring visit by checking all the new informed consent forms
at the site that were signed since the last monitoring visit. The monitor needs to first look at
the version the site has been using and should ensure that the site has the correct ICF version
along with the translations. The monitor also needs to ensure that the ICF process is
administered as per the regulatory, EC and the ICH- GCP guidelines. To ensure that all ICF’s
are properly signed and dated and that no trial activity is performed prior to the signing of the
informed consent form. To ensure that all the patients have received a copy of the signed ICF
and the same is documented in the patient document. The monitor needs to undertake the next
activity for example Study status and Review of CRF’s Prior to review of the CRF’s the
monitor needs to ensure that all the study related logs viz: Screening log, enrolment log,
patient visit log etc are updated and a copy of the same is taken for trial master files. The
monitor then needs to review CRF pages of all the patient visits that are performed after the
last monitoring visit. The monitor needs to check the eligibility criteria of the new patients
that are enrolled in the study. The monitor can request the team member responsible for the
completion of the CRF’s and obtain the required clarifications. Incase there is any change in
the data the same needs to be striked out first, initial and date the change in the original data.
Along with the CRF visit pages there may be other patient related documents viz. The
monitor has to perform 100% Source Data Verification for all patients for all visits at each of
the monitoring visit. The monitor should also complete the SDV forms during the SDV
process and should file a copy of the same in the site master file (SMF).The monitor needs to
ensure that the pending resolutions that were requested during the last visit are completed and
that the same is reviewed and documented in the monitoring report. The monitor needs to
ensure that all the CRF pages of the visits that are reviewed during the current monitoring
visit are retrieved from the site. The monitor also needs to ensure that all the CRF pages,
patient dairy pages, questionnaires or any other study related data should be arranged to be
sent to the data management following the right channel.