CCR Clinical Informatics

 

DCTD

(Division of Cancer Treatment and Diagnosis) sponsored studies with monitoring done via CTMS (Clinical Trials Monitoring Service), electronically report data to

Theradex

every two weeks according to the following calendar:

• CTMS 2011 Submission Calendar

Theradex Reference Documents

• Case Report Forms Codes

• Case Report Forms Manual and Data Submission Specifications

 

CTEP

(Cancer Therapy Evaluation Program) sponsored studies utilizing

CDUS

(Clinical Data Update System), electronically report data every quarter (January, April, July and October).

 

CTEP Reference Documents

• Protocol Development Documents and list of codes and values

• CTEP CDUS Instructions and Guidelines

 

For studies that do not submit data via CDUS, data must be submitted (manually) via the

CDS Application

This is also known as the CDUS Web Submission.

 

For PI initiated studies where industry is the sponsor, please remember that C3D might be able to be used and data transferred to the sponsor via a secured file transfer process. Ideally, this discussion needs to begin early in the collaborative process and the CTA, or other tech transfer agreement should include the data to be transferred and the time frame for transfer. The document below are the specifications that you can send to the sponsor to begin the dialogue on using C3D and how data transfer can occur:

 

C3D Electronic Data Submission Capabilities