2012 Consortia

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Consortia Organizational Rosters

Protocol Development

Protocol Status and Amendments

Adverse Events and Protocol Deviation *

COVID-19 is an emerging, rapidly evolving situation.

MEMORANDUM

* PLEASE NOTE: This is a reminder that infections occurring in subjects on clinical trials are considered adverse events and should be reported per protocol guidelines via normal procedures (via the MDS and via the SAE forms if serious).

Please document COVID-19 related adverse events as follows:

  • "Infections and infestations -Other, specify" in the Adverse Event field and "COVID-19" under the "Adverse Event Verbatim Term";
  • Please specify "documented" or "suspected" in the "Adverse Event Verbatim Term" (e.g., "COVID-19 - suspected" or "COVID-19 – documented" in the Verbatim Term).
  • Additionally, please record (and if applicable, report via the SAE form) any other Adverse Events the subject experiences such as Dyspnea, Acute respiratory distress syndrome, etc.

SAE specific instructions (this process is the same as our usual process):
Narrative: Identify all pertinent facts related to the COVID-19 infection including, but not limited to the following:

  • Presumptive vs confirmed diagnosis. If presumptive, please update your narrative if/when diagnosis is confirmed, including timelines;
  • Treatment information;
  • Recovery information, including timelines;
  • Outcome information/status; and
  • Supporting documentation: Please include supporting documentation including admission notes, progress notes, clinical visits, and discharge summary if/when available.

Agents/Drugs

Investigator Registration

Monitoring

Reports


Please e-mail dcphelpdesk@dcpais.com if you have any questions or concerns.