CNICS CONCEPT PROPOSAL APPLICATION PROCESS

 

Pre-Approval Steps

• Requesting and receiving data/specimens from the CNICS repository is initiated by submission of a Concept Proposal Application. The application contains instructions for electronic submission. Applications are accepted year around. Every concept proposal requires inclusion of a CNICS investigator from one of the CNICS sites. This is to facilitate the CP process, help to avoid overlap with existing proposals and assess feasibility of CP prior to completing a complete CP application. Any questions regarding the application process, including requests to identify a CNICS collaborator, may be directed to the CNICS Operations Center.

• Details of the review process for applications are outlined in the Concept Proposal SOP. A letter describing the comments from reviewers and a priority score will be provided to the investigator.

• Approved projects require further discussions and documentation before samples/data are transferred to investigators. Refer to CP Project Plans below. *Investigators are required to pay for costs associated with processing and shipment of specimens*

• Projects which are not approved may be revised according the reviewer’s comments or the decision may be appealed as described in section 3.4.4 in the Concept Proposal SOP.

 

Approved Projects:

• Once a concept proposal is approved, Project Plans must be submitted electronically to the CNICS Operations Center as described below.

  Project Plans:

   - Complete team members list

   - Detailed Analysis Plan for Data/Specimens

   - For specimen requests, submit a completed Subject/Specimen Characteristics Checklist.

• A conference call will be scheduled with the entire study team to discuss/approve the Project Plans.

• Local IRB review and approval must be obtained and sent to the CNICS Operations Center. Available data/specimens will be transferred to investigators upon approval of Project Plans. *Investigators are required to pay for costs associated with processing and shipment of specimens*

 

After Specimen/Data Transfer:

• A CNICS progress report form should be reported to the Research Coordinating Committee (RCC) at 6 months.

• Any findings to be published as a result of a CNICS-approved Concept Proposal must be reviewed by the RCC prior to submission. Findings should be submitted electronically to the CNICS Operations Center.

   - Please allow 1 week for approval of abstracts prior to submission.

   - Please allow 2 weeks for approval of manuscripts prior to submission.