PRINCIPAL
INVESTIGATORS AND DELEGATION OF STUDY-RELATED TASKS TO
CO-INVESTIGATORS AND STUDY STAFF
The
Principal Investigator (PI) is responsible for personally
conducting or supervising the study. However, PIs are
allowed to delegate certain study-related tasks to co-investigators
and study staff. When tasks are delegated, the PI is responsible
for providing adequate supervision of those to whom tasks
are delegated and is accountable for regulatory violations
resulting from failure to adequately supervise the conduct
of the study.
When
delegating study-related tasks to co-investigators and
study staff, the PI must ensure that:
- Designated
individuals are qualified to perform such tasks
The
PI must ensure that any individual to whom a task
is delegated is qualified by education, training,
and experience to perform the delegated task.
When
delegating tasks that are clinical or medical in nature,
such as evaluating study subjects to assess clinical
response to an investigational therapy (e.g., global
assessment scales, vital signs) or providing study-related
medical care to subjects, the PI must ensure that
the individual has the relevant formal medical training
and, when appropriate, licensing and/or certification.
Examples
of inappropriate delegation include:
-
Screening evaluations, including obtaining medical histories
and assessment of inclusion/exclusion criteria, conducted
by individuals with inadequate medical training;
-
Physical examinations performed by unqualified personnel;
-
Evaluation of adverse events by individuals lacking
appropriate medical training, knowledge of the clinical
protocol, and knowledge of the investigational product;
-
Assessments of primary study endpoints (e.g., tumor
response, global assessment scales) by individuals lacking
appropriate medical training and knowledge of the protocol;
or
-
Informed consent obtained by individuals who lack the
medical training, knowledge of the clinical protocol,
or familiarity with the investigational product needed
to be able to discuss the risks and benefits of a clinical
trial with prospective subjects. Note: For most studies
involving more than minimal risk and all studies involving
investigational drugs/devices, the PHRC requires that
a licensed physician investigator listed on the protocol
obtain informed consent.
Investigators
are advised to maintain a list of the appropriately
qualified persons to whom significant study-related
tasks have been delegated. This list should also describe
the delegated tasks, identify the training that individuals
have received that qualifies them to perform delegated
tasks, and identify the dates of involvement in the
study. Note: The Partners Human Research Quality Improvement
Program has developed a Study
Site Signature/Delegation of Responsibility Log
which may be used for this purpose.
- Co-investigators
and study staff receive adequate training on how to
conduct the delegated tasks and are provided with an
adequate understanding of the study
The
PI should ensure that there is adequate training for
all staff participating in the conduct of the study.
The investigator should specifically anticipate the
possibility of staff turnover during the conduct of
the study (particularly if the study is of long duration)
and plan to ensure that there is adequate training
of any replacement staff.
The
PI must ensure that co-investigators and study staff:
- Have
a specific understanding of the details of the protocol
relevant to the tasks they will be performing and, when
applicable, the investigational product;
-
Are aware of regulatory requirements and acceptable
standards for the conduct of human-subjects research,
both with respect to conduct of the study and human
subject protection;
-
Are competent and credentialed to perform the delegated
tasks ; and
-
Are informed of any pertinent changes to the protocol
during the conduct of the study and are educated or
given additional training as appropriate.
If
the sponsor provides training materials for investigators
in the conduct of the study, the PI must ensure that
staff receives and reviews these materials and/or participates
as necessary in any in person training sessions pertinent
to their role in the study.
- There
is adequate supervision and involvement in the ongoing
conduct of the study
The
PI must have a detailed plan for the supervision and
oversight of a study. Supervision and oversight should
be provided even for individuals who are highly qualified
and experienced. A plan might include the following
elements, to the extent they apply to a particular
study:
- Routine
meetings with co-investigators and study staff to review
progress of the study and update them on any changes
to the study or other procedures;
-
Routine meetings with the sponsor’s monitors;
-
A procedure for correcting problems identified by co-investigators
or study staff, outside monitors or auditors, or other
parties involved in the conduct of a study;
-
A procedure for documenting the performance of delegated
tasks in a satisfactory manner and, where appropriate,
verifying findings (e.g., observation of the performance
of selected assessments or independent verification
by repeating selected assessments);
-
A procedure for ensuring that the consent process is
being conducted in accordance with federal regulations
45
CFR 46 and 21
CFR 50 and PHRC
requirements and that study subjects understand
the nature of their participation, risks, etc.;
-
A procedure for ensuring that information in source
documents is accurately captured on the Data Collection
Forms, Case Report Forms, or elsewhere as appropriate
to the study;
-
A procedure for dealing with data queries and discrepancies
identified by the study monitor or other individuals
responsible for oversight of the study; and/or
-
Procedures for ensuring co-investigators and study staff
comply with the IRB-approved protocol and reporting
requirements of the IRB and sponsor.
Guidance
based on United States. U.S. Dept. of Health and Human
Services, Food and Drug Administration, et al. Guidance
for Industry: Protecting the Rights, Safety, and Welfare
of Study Subjects – Supervisory Responsibilities of Investigators.
Draft Guidance May 2007 |