TEMPLATE FOR MONITORING PLAN
To be adapted as required for the protocol
Clinical trial monitoring will be performed by [name of company providing
monitoring services] and monitors will be appointed to specific regions. The
Regional monitor to oversee all monitoring for the study will be [name of
monitoring manager] (include or delete as required)
The clinical monitors as representatives of [SPONSOR], have the obligation to
follow the study closely. In order to achieve this, the monitors will visit the
Principal and Sub Investigators and study centre/s at periodic intervals, in
addition to maintaining necessary telephonic and written communication. The
monitors will maintain current personal knowledge of the study through
observation, review of study records and source documentation and discussion
of the conduct of the study with the Principal and Sub Investigators and their
All aspects of the study will be closely monitored by [SPONSOR] or its designee,
for compliance with applicable government regulations with respect to current
Good Clinical Practice (GCP) and current Standard Operating Procedures
An initiation visit will be performed during [month] to ensure that the site
personnel have been thoroughly trained and the site is provided with all clinical
The trial will only commence after receipt of final approvals from the Medicines
Control Council and Ethics Committee/s.
The site/s will allow the study monitors, sponsor representatives, and any
representatives of regulatory authorities, direct access to all study documents,
medical files, and source data to enable verification of the trial data, whilst
maintaining the anonymity of the participant and confidentiality of the data.
The first monitoring visit will be conducted in [month, year] shortly after the first
participant has been enrolled to ensure that criteria for inclusion and exclusion
have been met and that all protocol procedures are being followed appropriately.
All patients enrolled will be verified to have met all inclusion criteria.
Subsequent monitoring visits will depend on retention of patients in the study and
recruitment at each site. Sites will be monitored approximately every [number]
weeks [or enter the intervals, dates of proposed monitoring visits] depending on
the demands of the study and the number of patients enrolled at each site
(average frequency of [n] weeks), starting [n] to [n] business days after the first
patient is screened at each study centre
Alternate wording depending on study:
The patients will be dosed in dose groups. The first monitoring visit will be
conducted shortly after the first dose group has been successfully screened at
the each site to ensure that criteria for inclusion and exclusion have been met
and that all protocol procedures are being followed appropriately. All patients
screened will be verified to have met all inclusion criteria up at the time of the
Screening visit. The monitor will then remain at site to witness dosing and the
initial PK assessments for the first group of participants.
A total of [n] monitoring visit/s have been allocated to each site with each visit
requiring the monitor to be at the site for [n hours/days]. This time is considered
to be adequate for the comprehensive monitoring of the records
General text:- usually suitable for all protocols
The following will be checked at each monitoring visit:
Informed consent has been signed by the participants prior to any study
specific procedures being conducted
Participant inclusion and protocol compliance
Case report form completion
Source document verification against Case Report Forms (including ECG
and clinical lab results)
Investigator Site File for availability of essential documents and
maintenance of site monitoring logs.
Identification, tracking and electronic resolution of data queries .
Verification of IP storage, dispensing and accountability
Verification of laboratory specimen collection, storage and shipping
Reporting of adverse events as per the protocol
Facilities remain acceptable
The investigational team is adhering to the protocol as well as the ICH and
SA GCP guidelines
QA Audits and Inspections
Internal checking by the PAREXEL quality specialists at the PAREXEL sites will
be carried out at all stages of the study. Similar procedures are also in place at
each of the other sites thus ensuring quality data.
If necessary, a quality assurance audit will be carried out by independent
auditors to make sure that the trial has been conducted according to the protocol
and the applicable regulations.
Closure of Study
A Site Close-Out Visit will be conducted after all participants have completed the
study and all queries have been answered. At this visit the monitors will ensure
that all trial documentation is in place, all investigational product has been
accounted for and returned or destroyed, and will discuss archiving procedures
with the site.
Communication between visits
Between monitoring visits, investigators will be telephoned regularly by the
monitors to verify patient enrolment status, review study progress, answer
protocol questions, CRF completion status and queries, and to ensure that the
study proceeds in a timely manner.
In addition the monitors will discuss adverse events and confirm that any SAEs
have been appropriately documented and reported to the Sponsor and the
Site telephone contacts will be documented on contact report form and a copy
faxed to the site when discussions involve significant issues. All site contacts,
including e-mails, are to be printed, signed and dated. They will become part of
the Investigator Site File and Trial Master File.
Regular teleconferences will be held between the monitor, the Project Manager,
the PAREXEL and other sites and the sponsor.