Data managers are an integral part of most research teams, and their services have a profound impact on the quality and efficiency of the research process.
De-Mystifying Electronic Consent (E-Consent): Understanding Options for Implementing E-Consent for Research
December 7, 2023 | 11:00 am- Noon
This session will provide an overview of the regulatory and institutional requirements related to the use of an electronic consent process for research studies and review the various options available to study teams at Johns Hopkins who seek to implement an e-consent process. Panelists will review IRB requirements for e-consent and provide practical advice about use of DocuSign and REDCap to support e-consent in research.
Speakers: Megan Singleton, JD, MBE, CIP, Scott Carey, and Bob Lange
Data Manager’s Advisory Board
The board is designed to focus on data management within clinical research studies, including ways in which data management impacts study efficiency and the value of the data for both primary and secondary uses. Within Johns Hopkins there are a wide range of approaches to data management, with most of the responsibility centered within the individual studies. There are a few centers of expertise related to database management that have not generally met with each other or collaborated with each other to create institutional approaches and standards.
The Data Manager’s Advisory Board will work to answer the following questions:
- What are logical ways to group protocols in ways that the approach to data management is relatively consistent? (examples: individual prospective RCTs, retrospective reviews of patient data, multi-institutional protocols that utilize clinical data and research data)
- How should database management systems be rated? (ease of use, cost, ability to share data, security, data entry and capture, etc) Could this be communicated to faculty looking for assistance?
- What are the best practices for database management? What database management practices and processes should be discouraged or prohibited? Should there be a greater emphasis on data management plans in the IRB and ICTR review of protocols?
- Should Johns Hopkins provide a central office to support data management? If there was a charge to investigators, how would services be priced?
- What specific services should be supported? Database design based on the aims of the study, data capture and entry, interfaces with laboratory and clinical instruments, etc. Does Johns Hopkins have the right personnel to support data management?
- Should we standardize on 2-4 key databases to support the wide need of investigators? From small to large studies? Which data dictionaries should we use? Should we provide database access on enterprise or smaller unit servers (like ICTR), with appropriate processes for data security and backup?
Data Manager’s Interest Group (DMIG)
The goal of this group, formed at the recommendation of the Data Manager’s Advisory Board, is to create an environment where data managers from throughout Johns Hopkins can meet to share expertise and discuss the challenges of their unique roles in the research enterprise.
If you wish to subscribe to the group’s listserv, visit https://lists.johnshopkins.edu/sympa/info/datamgrs and select ‘Subscribe’ from the menu on the left side of the page.
November 4, 2021
The BEAD Core | Recording
Speaker- Jacky Jennings, PhD, MPH