Principles and Practice of Pharmaceutical Medicine

the investigator and sub-investigator(s), the study
coordinator or research nurse, pharmacist and
laboratory personnel or specialists as needed.
During the meeting, all major points and
requirements of the protocol are reviewed and
discussed. Procedures for subject enrollment are
particularly important as this is the area that may
cause most of the problems for the site. During the
presentation, participants may raise important
medical or logistical issues that have or have not
been anticipated by the protocol authors. It is
important to note these concerns and communicate
them to the protocol authors, as appropriate.
The sponsor’s representative should be compe-
tent in the basic medical and scientific issues of
the investigational product and protocol, know the
target disease or symptoms, be able to train the
investigative staff on the conduct of the study,
confirm facility capabilities, conduct the site initia-
tion meeting, describe adverse event reporting
requirements and be able to resolve protocol issues
during and after meeting.

Conducting clinical trial monitoring

Clinical trial monitoring includes those activities
that ensure that the study is being conducted
according to the protocol. Monitoring permits an
in-process assessment of the quality of the data
being collected. The first alert to safety issues is
often revealed during the process of monitoring the
clinical trial.
Monitoring clinical studies involves the act of
overseeing the progress of a clinical trial. Monitors
ensure that the study is conducted, recorded and

reported in accordance with the protocol. This is

accomplished by the review of paper CRFs or paper

copies of electronic DCTs on-site for possible

errors, inconsistencies and omissions. The monitor

identifies errors and discrepancies that require dis-

cussion with the investigator or staff and any safety

questions or issues. The monitor compares CRFs

with source documents (source document verifica-

tion or SDV), confirming that source data are con-

sistent with CRF entries, identifies all serious

adverse events (SAEs), resolves previous and cur-

rent data queries and confirms completeness of

investigator records and files.

To be a successful monitor, the sponsor repre-

sentative should know how to interpret hospital/

clinic records/charts, laboratory tests and interpre-

tations, query resolution procedures, protocol and

CRF data requirements, medical nomenclature,

SAE procedures and health authority require-

ments. In addition, a monitor needs to have excel-

lent interpersonal communication and problem-

solving skills.

Clinical monitoring requires clinical, interpretive

and administrative skills. The monitor needs to

confirm subject selection and patient enrollment

compliance. Quality monitoring will always include

and confirm the following activities:

properly obtained informed consent;

adherence to the protocol procedures and inclu-

sion/exclusion criteria;

transcription of data from source documents to

the CRF that is both consistent and logical;

identification of any safety issues including

SAEs;

proper accountability and reconciliation of drug

supplies;

continued adequacy of facilities and staffing.

The frequency of clinical monitoring depends on

the actual accrual rate of the subjects. Complex

studies may need to be visited more frequently

depending on the accrual rate of subjects, the

Table 3.4 Key study documentation

Approved protocol and CRF
Informed Consent Form and Subject Information
Sheet
Investigator’s CV
Written IRB/IEC approval
Local regulatory approval
Signed study contract
Laboratory ranges and accreditation

34 CH3 CLINICAL RESEARCH EDUCATION AND TRAINING FOR BIOPHARMACEUTICAL STAFF