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TADS Add-On Procedures 6/14/00
TADS Policy on Add-On Studies
Add-on Proposal Overview
According to NIMH procedures documented in PA PAR-00-095 “Ancillary Studies to NIMH Multi-Site Trials, investigators in or outside TADS may propose a TADS add-on. The purpose of ancillary studies is to promote innovative lines of scientific inquiry regarding the understanding and treatment of mental disorders. Ancillary studies may use subjects recruited in a trial; may be an expansion into a new (related) population at some or all of the clinical sites participating in the trial; or may simply share methods and measures with the trial.
Before submitting an add-on study proposal, the applicant should be familiar with (1) the NIMH Program Announcement addressing add-on studies for NIMH contract multi-site-trials, which can be found at and (2) the TADS protocol and procedures for TADS add-on studies (this document) both of which are available from the TADS Coordinating Center (CC) or on the web at
Please note that add-on studies will not be mentioned to subjects until after consent for the main study, using a separate supplemental consent.
Submission Procedures
All requests for the TADS protocol, questions regarding add-on proposals and add-on proposals should be sent by email to the PI of the TADS Coordinating Center, Dr. John S. March: .
With the TADS Cooperative Group, any site may propose an add-on study for itself, several, or all sites. Insofar as possible, other sites should be invited to participate. Add-on proposals from non-TADS sites will use the same criteria used for add-on studies proposed by a TADS site.
To propose an add-on, the proposing site should provide the CC the following (1) a 1-2 page protocol that would in general be similar to what would be required for an IRB submission, including scientific background, specific aims, methods, data analysis and human subjects; (2) a consent form and (3) a cover letter that addresses the following issues:
Involvement of TADS sites.
Use of TADS core data.
Additional measures and procedures, integration with TADS procedures, and specific discussion of subject and investigator burden.
Potential for the add-on to interfere with the TADS protocol or to induce site-by-treatment interactions.
Budgetary feasibility should be established, but a detailed budget is not required. Since TADS funds cannot be used for add-ons, a potential sponsor or funding source should be identified.
Role and responsibility of the TADS Coordinating Center must be specified
Authorship intent.
Before submitting a formal proposal, the PI of the putative add-on may wish to briefly discuss with Dr. March the appropriateness of the proposal and degree of overlap with core TADS questions/measures or with previously approved add-on studies.
Approval procedures
TADS will use a two-level review process to consider the merits of add-on proposals. First, the TADS CC in conjunction with NIMH Program Staff will review each proposal to assess scientific merit and feasibility within the overall context of the TADS protocol. Second, if the add-on passes initial review, the proposal will be submitted to the TADS Ancillary Studies Committee, which in this case is defined as the TADS Steering Committee.
The CC will circulate the proposal for discussion on the weekly TADS conference call. In the case of proposals that originate outside the TADS SC, the PI and, if necessary, collaborating scientists will be invited to join the conference call.
Each add-on study requires specific Steering Committee approval before it can be initiated. Conforming to standard SC procedures, each site will have one vote. With the proposing site abstaining, a simple majority of the SC (one vote per the 10 sites less the proposing site plus the CC and NIMH) must approve the add-on.
Suggested criteria for evaluating the soundness of add-on studies include the following: scientific merit, relatedness to TADS, uniqueness, minimal overlap with TADS measures, subject and investigator burden, feasibility and funding.
TADS funds cannot be used for add-ons.
If the add-on is for all sites, all sites must approve (unanimous). Failure to attain unanimous approval would not preclude the proposing site from resubmitting the add-on to be administered by a subset of sites, but in no case would a site be required to participate.
If at any point prior to or after approval the CC and the NIMH agree that the add-on conflicts with the scientific or budgetary integrity of TADS, they may veto or cancel the add-on even if a TADS site or sites wish to do it.
Publication procedures
Publications originating from add-on studies will be the responsibility of the proposing and participating sites. A description of any add-on study publications should be circulated to all sites, including the CC and NIMH, as a courtesy.
Where more than one TADS site participates in an "add-on, the lead author for the main paper from that add-on will be from the proposing site and each cooperating site may supply a co-author. The lead author may choose additional co-authors from any site, including those that did not participate in gathering add-on data. Proposals from non-TADS sites should pre-specify how authorship will be managed insofar as possible.
If an add-on paper includes analysis of common protocol data other than demographic data, it must go through the same approval procedures as other papers using common protocol data.
Because TADS will publish a series of methods and treatment outcome papers, no add-on paper focused on baseline data may be published before the main descriptive TADS method paper(s). Similarly, no add-on publication comparing or contrasting treatment groups on any measure may be submitted before the TADS primary and core-secondary treatment outcome papers have been accepted for publication.