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Sabol ME, Finkle J, Krucoff M, et al. Cardiac Safety Research Consortium (CSRC): Cardiovascular Safety and Adverse Event Case Report Forms. Ther Innov Regul Sci. 2015;49(4):511-513doi: 10.1177/2168479014567319.
Sabol, M. E., Finkle, J., Krucoff, M., Stockbridge, N., Parkhill, N., Shinagawa, K., Mahaffey, K., Tcheng, J., Lenihan, D., Melloni, C., Todaro, T., Michelson, E., Munley, J., Zander, J., & Oh, R. (2015). Cardiac Safety Research Consortium (CSRC): Cardiovascular Safety and Adverse Event Case Report Forms. Therapeutic innovation & regulatory science, 49(4), 511-513. https://doi.org/10.1177/2168479014567319
Sabol, Mary Elizabeth, et al. "Cardiac Safety Research Consortium (CSRC): Cardiovascular Safety and Adverse Event Case Report Forms." Therapeutic innovation & regulatory science vol. 49,4 (2015): 511-513. doi: https://doi.org/10.1177/2168479014567319
Sabol ME, Finkle J, Krucoff M, Stockbridge N, Parkhill N, Shinagawa K, Mahaffey K, Tcheng J, Lenihan D, Melloni C, Todaro T, Michelson E, Munley J, Zander J, Oh R. Cardiac Safety Research Consortium (CSRC): Cardiovascular Safety and Adverse Event Case Report Forms. Ther Innov Regul Sci. 2015 Jul;49(4):511-513. doi: 10.1177/2168479014567319. PMID: 30222439.
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Ther Innov Regul Sci. 2015 Jul;49(4):511-513. doi: 10.1177/2168479014567319.

Cardiac Safety Research Consortium (CSRC): Cardiovascular Safety and Adverse Event Case Report Forms.

Therapeutic innovation & regulatory science

Mary Elizabeth Sabol, John Finkle, Mitch Krucoff, Norman Stockbridge, Nancy Parkhill, Kaori Shinagawa, Kenneth Mahaffey, James Tcheng, Daniel Lenihan, Chiara Melloni, Thomas Todaro, Eric Michelson, Jiefen Munley, Judith Zander, Richard Oh

Affiliations

  1. 1 Global Clinical Safety and Pharmacovigilance, GSK, Collegeville, Upper Providence, PA, USA.
  2. 2 Duke University Medical Center, Durham, NC, USA.
  3. 3 FDA White Oak, Silver Spring, MD, USA.
  4. 4 Health Canada, Ottawa, Ontario, Canada.
  5. 5 PMDA, Tokyo, Japan.
  6. 6 Stanford University, Stanford, CA, USA.
  7. 7 Vanderbilt University, Nashville, TN, USA.
  8. 8 Duke Clinical Research Institute, Durham, NC, USA.
  9. 9 Medpace, Cincinnati, OH, USA.
  10. 10 AstraZeneca, Wilmington, DE, USA.
  11. 11 Takeda, Deerfield, IL, USA.

PMID: 30222439 DOI: 10.1177/2168479014567319

Abstract

Detection of off-target cardiovascular (CV) effects remains a significant challenge to drug development. Documentation of CV events in non-CV trials is often inadequate to interpret imbalances between treatment arms, which may lead to concerns about potential CV safety "signals." The Cardiac Safety Research Consortium (CSRC) public-private partnership has developed CV case report forms (CRFs) for adverse CV events, including death. These CRFs are intended to encourage collection, as near to the occurrence of an event as possible, of the minimum information necessary to assess, or possibly adjudicate, the event. A broad range of stakeholders (representing industry, academia, and regulatory authorities) developed these forms with the goal of balancing the collection of key information with the resources likely to be available. Use of these forms is optional, and sponsors may modify them. These forms have not undergone any type of "validation" process. The CSRC will continue to sponsor a working group to invite public comment and feedback on these forms.

Keywords: CSRC; cardiovascular events; cardiovascular signals; case report forms

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