MGH Division of Clinical Research

REDCap – CT.gov Adverse Event Reporting Module

Ended: Nov. 6, 2019

REDCap – CT.gov Adverse Event Reporting Module:
Speaker:
• Eduardo Morales, Systems Designer - Enterprise Research Infrastructure & Services (ERIS)
This session reviews the Adverse Event Reporting module developed by Eduardo Morales of the REDCap team. This module is designed to generate Adverse Event reports needed by investigators at different time points for different requirements. It can connect and load data from an existing REDCap project or it can act as and additional REDCap project that collects AE data. The REDCap AE Reporting External module can facilitate Investigator and Institutional compliance by facilitating the creation of aggregate Adverse Event (AE) reports for:

1. ClinicalTrials.gov (CTgov) AE results reporting module
2. Aggregate AE reporting to your Institutional Review Board (IRB)
3. Summary AE reporting for the Food and Drug Administration (FDA) Investigational

Learning Objectives:
1. Summary of module and its function
2. How to set up module in REDCap
3. Demo of how module works on example project

Target Audience: Researchers who’s projects require reporting adverse events to one of the previously mentioned organizations



Category:
Data & Analytics

Sponsor:
MGH Division of Clinical Research

Sessions

Nov. 6, 2019 11/6/19
2PM-3:30PM 		2 PM – 3:30 PM
Simches 3.110, Floor 3, Simches Research Center

Reviews

Anonymous: Great intro to REDCap updates to facilitate studies going forward. Presenter was knowledgeable about the field and answered questions perfectly! Will definitely be implementing what we learnt in our studies going forward.
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Date Reviewed: Jan. 21, 2020, 4:58 p.m.
Susanne H: Great intro to the new external module! In the demo, a lot of things were not easy to decipher (it was too small to see details), but it looked promising. As usual, the REDCap team was very attentive to questions - thanks!
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Date Attended: Nov. 6, 2019, 2 p.m.
Date Reviewed: Nov. 6, 2019, 4:38 p.m.
Devin Q: The demo portion of the presentation was hard to view in the format provided, but the content was very helpful.
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Date Attended: Nov. 6, 2019, 2 p.m.
Date Reviewed: Nov. 6, 2019, 3:10 p.m.
Ayobami O:
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Date Attended: Nov. 6, 2019, 2:25 p.m.
Date Reviewed: Nov. 6, 2019, 3:08 p.m.