Ancillary Study and Data Request Forms

Ancillary Studies

Ancillary Studies are defined as investigations that are not described in the original protocol and that require additional data collection or laboratory sample analyses to be performed.  Ancillary Studies can be either retrospective or prospective in nature.  Examples of Ancillary Studies include studies that require analyses of biological specimens, collection of additional specimens, administration of behavioral surveys, conduct of focus group discussions, etc.

 

An Ancillary Study Application must be completed by the investigator proposing the study; the completed Ancillary Study Application must then be submitted to the FHI 360 Clinical Research Manager (CRM) for the protocol.  Non-MTN investigators must also fill out an MTN Materials Transfer Agreement (MTA) if the request involves the use of stored specimens from an MTN study. See the MTN Manual of Operations, Section 21 Ancillary Study Proposals, Secondary Data Analysis Requests and Requests for Datasets for further details regarding the approval process for Ancillary Study Proposals and MTA requirements.

 

Click here to access our Ancillary Study Application

 

Secondary Data Analyses

Secondary Data Analyses are analyses, different from those performed for the protocol objectives, which are requested by an investigator to write an abstract, manuscript or other scientific publication, and/or to present at a meeting or conference.  Secondary data analyses may be requested while a study is ongoing, or after follow-up or closeout has been completed. They are retrospective in nature, involving data previously collected as part of an MTN trial but not requiring additional procedures or analyses of specimens.  These may include site-specific data analyses.  Secondary Data Analyses may require additional statistical support.

 

A Secondary Data Analyses Request Form must be completed by the investigator requesting the analyses; the completed Secondary Data Analyses Request Form must then be submitted to the FHI 360 Clinical Research Manager (CRM) for the protocol.  See the MTN Manual of Operations, Section 21 Ancillary Study Proposals, Secondary Data Analysis Requests and Requests for Datasets for further details regarding the approval process for Secondary Data Analyses Requests.

 

Click here to access our Secondary Data Analysis Request Form 

 

Requests for Datasets

Requests for datasets are occasionally made by researchers conducting their own investigations (usually for PhD dissertations). These requests for datasets also must be approved.

 

A Dataset Request Form must be completed by the investigator requesting the data; the completed form must then be submitted to the FHI 360 Clinical Research Manager (CRM) for the protocol.  See the MTN Manual of Operations, Section 21 Ancillary Study Proposals, Secondary Data Analysis Requests and Requests for Datasets for further details regarding the approval process for dataset requests.

 

Click here to access our Dataset Request Form

 

Looking instead to propose a protocol?

Information on how to submit a Protocol Concept Proposal can be found here.