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ATTACHMENT 1 - Sample Format
Clinical Trials Cooperative Group Guidelines
MODALITY COMMITTEE SUMMARY OF ACTIVITIES
A modality committee is herein defined as a medically
specialized committee which is not disease-specific. Examples
include committees for pathology, radiation oncology, surgery,
transplant, immunology, etc.
For each MODALITY COMMITTEE prepare a separate summary of the
activities of that committee, utilizing the following format:
I. ADMINISTRATIVE ASPECTS
- Define the functions of the committee, describing the
scope of its responsibilities, the frequencies of its
meetings, and membership requirements.
- Describe the role of each of the modality committees in
the various activities of the Group, including items such
as service by members on executive and administrative
committees, participation in Group meetings, and
specialized review for various disease areas.
II. SCIENTIFIC CONTRIBUTIONS
- Briefly describe the process by which the modality
discipline contributes to protocol initiation, design and
monitoring.
- Describe the major scientific accomplishments of the
modality committee during the current award period.
- Briefly describe the most important scientific plans and
goals of the committee for the upcoming award period.
III. QUALITY CONTROL PROGRAMS
A. PATHOLOGY
- Describe the process employed by the Group for pathology
review.
- Describe the process involved in deciding whether to
conduct pathology review in a protocol under development.
Does the Group have its own data from previous studies on
which to base a decision not to perform pathology review?
- Describe the mechanism by which the Group ensures prompt
submission of pathology review materials from member
institutions and how pathology review impacts upon
therapy.
- How many Phase III studies were active at the time of
submission of the competing application? What percentage
of these studies require pathology review?
- What is the annual number of patient accessions in each
of the past 3 years into protocols for which pathology
review is being conducted? For each year, provide the
percentage of reviews which have been completed.
- Does the Group audit a percentage of cases with pathology
review in protocols which do not have standard pathology
review?
- Are pathologists involved in protocol design and
development?
- What percentage of trials with pathology requirements
included pathologists among the principal
investigators/study chairs?
B. RADIATION THERAPY
1. Discuss the radiation review process for the Group,
including such issues as:
- the decision during protocol development to include
radiotherapy review
- what is evaluated during the review
- who conducts the review
- who receives the results of the review
- how port film and physics reviews are performed and
integrated
- the requirement for simulators for each participating
institution
- how radiation therapy review is incorporated into
institutional performance assessment
2. For those protocols which involve radiation therapy:
- what percentage of the Group's active phase III protocols
involve radiation therapy?
- what percentage has a radiotherapy co-chairman?
- which protocols require radiotherapy quality control
review?
- which protocols require rapid turnaround review?
3. Describe Group interactions with the Radiologic Physics
Center
4. Discuss the mechanism employed by the Group to ensure
prompt submission of radiotherapy materials by member and
affiliate institutions.
C. SURGERY
- Describe the process by which surgical quality control
review is conducted by the Group. Is the review conducted
by surgeons? Does it include review of operative data,
protocol-specific surgical data forms, and pathology
reports?
- What proportion of the active Phase III protocols with a
surgical component presently require surgical quality
control review? What were the annual patient accessions
for the past three years into protocols requiring
surgical quality control? For what percentage of these
has quality control been completed?
- Briefly describe the mechanism by which the Group ensures
prompt submission of surgical quality control review
materials from member institutions.
- Are surgeons involved in protocol design and development?
- What percentage of trials included surgeons among the
principal investigators/study chairs?
- Does the Group have a surgical handbook of standards for
acceptable surgical procedures to aid with protocol
development?
D. OTHER MODALITY COMMITTEES (e.g., Chemotherapy): Please
follow the above general format in submitting summary
information.
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