Skip to main content
. Author manuscript; available in PMC: 2018 Jan 24.
Published in final edited form as: Contemp Clin Trials. 2013 Aug 31;36(2):406–413. doi: 10.1016/j.cct.2013.08.010

Table 1.

COPTR Subcommittees

Subcommittee Examples of Subcommittee Functions

Intervention Reviews and enhances main trial intervention with lessons learned from phase 1 (e.g., pilot studies), and trouble shoots intervention challenges.
Reviews, enhances and monitors process evaluation measures and other assessments of intervention quality.
Discusses procedures to enhance intervention retention along with the project coordinators working group

Measurement Reviews and enhances study designs for the main trials to insure adequate statistical power to quantify precisely specified intervention effects for the primary outcomes.
Proposes new measures for the study as a whole. Reviews all measures and measurement tools and recommends common measures to be collected at multiple sites.
Reviews and enhances data capture and analysis methods, plans and implements those methods when pertinent to common measures.

Recruitment, Consent, Retention and Adverse Events Reviews subject eligibility criteria and recruitment plans at each Center and proposes strategies to promote recruitment and retention.
Works with the Coordinating Center to develop monitoring forms and monitors recruitment and retention and adverse events.
Discusses methods to enhance recruitment and retention in sites that face challenges achieving their targeted enrollment or retention.

Publications, Presentations, and Ancillary Studies Develops and recommends to the Steering Committee study policies regarding publications, ancillary studies and access to data from the COPTR studies.
Records and reports all manuscript proposals, abstract submissions and publications proposed by investigators.
Reviews, advises and approves all proposed ancillary studies and ensure that they do not adversely affect the main COPTR trial. Submits proposed ancillary studies to the Steering Committee for approval.

Early Stage Investigator Early Stage Investigators (ESIs) are new investigators who are within 10 years of having completed terminal research degree or medical residency and have not been awarded an NIH Research Project Grant. Each field site has at least one ESI who is included in the study to develop a cadre of investigators involved in childhood obesity research. Activities include monthly meetings; discussions on publications, presentations, and ancillary studies; and networking and sharing of research ideas.
HHS Vulnerability Disclosure