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Grant Application Toolkit: Regulatory Knowledge and Support

REGULATORY KNOWLEDGE AND SUPPORT  /  DSMB  /  ACDA  /  ACTA  /  CONSULTS

  AVAILABLE RESOURCES

 

Regulatory Knowledge and Support

The CCTS Regulatory Knowledge and Support (RKS) program provides consultation for reviewing, and assistance with drafting protocols, consent documents, and data and safety monitoring plans (DSMP).

Data and Safety Monitoring Boards (DSMB)


Data and safety monitoring plans help outline processes that promote safe study conduct. Consultation for developing and drafting Data Safety and Monitoring Plans (DSMP), as well as establishing and operating Data and Safety Monitoring Boards (DSMB), is available through CCTS Regulatory Knowledge & Support Service.

Learn how to access DSMB support

Accelerated Confidential Disclosure Agreement (ACDA)


With the use of the Accelerated Confidential Disclosure Agreement (ACDA) template, protocols can be obtained by participating sites without confidentiality agreement negotiation delays, placing those sites at an advantage to initiating trials earlier than current processes permit.

Learn how to access ACDA support

Accelerated Clinical Trial Agreement (ACTA)


Institutions and Industry partnering to reduce clinical trial contracting delays. The goal of the Accelerated Clinical Trial Agreement (ACTA) initiative has been to develop an efficient contract for sponsor-initiated multi-site trials. This streamlined process will allow sites to participate in clinical trials earlier in the process without undue delays in contract negotiations.

Learn how to access ACTA support

Consults


Regulatory Knowledge and Support (RKS) provides consultation for reviewing, and assistance with drafting protocols, consent documents, and data and safety monitoring plans (DSMP). Regulatory and ethics support services provided by RKS can be accessed through the Computerized Research Record (CoRR).

Learn how to access Regulatory Consults

 

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Related Pages

Grant Application Toolkit
Regulatory and Ethics
Acknowledging CTSA grant support in publications

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