STEPS TO STUDY ACTIVATION

Build Out Study Database

Principal Investigators are responsible for creating study databases that appropriately collect and protect data consistent with the investigator-initiated research study protocol. Information regarding the study database, and its appropriate data protections must be included in the IRB application for the protocol. More information about the IRB submission process can be viewed here. The study database should include the following features:

- - Audit trail
  - Individual Login
  - Restricted access

For more information on data storage, please see the HRPP Policy on Research Data Management and the Storage at IU website.

Study Database Build Support

If the Principal Investigator would like assistance with the creation and/or maintenance of a study database, the IU Biostatistics department is available for support. Biostatistics can also assist with quality control of the database, if contracted to do so. For NIH grant submissions in which Biostatistics is doing data management, they will also work with the PI to create the Data Management Sharing Plan for the grant submission.

For cancer center studies, please complete the Biostatistics Service Request form found here.
For non-cancer center studies, visit the Biostatistics and Health Data Science website to review services provided or contact George Eckert at geckert@iu.edu or Jing Su at su1@iu.edu.

For additional information regarding monitoring and auditing, please refer to the Develop Data and Safety Monitoring Plan (DSMP).

Available Database Applications

Depending on the type of research and federal requirements, the use of certain databases is highly encouraged. Some studies require registration in OnCore based on certain study criteria — see the Decision Tree to see if your trial requires entry into OnCore at IU.

REDCap (Research Electronic Data Capture)

REDCap is available at https://redcap.uits.iu.edu/
REDCap is a versatile tool for data collection and management, allowing researchers to design surveys, collect data, and manage it securely. It is ideal for a wide range of studies, including non-clinical research. REDCap can also be used for electronic consent for studies that are not FDA-regulated.
REDCap is not compliant with 21 CFR Part 11.
The IU REDCap team offers system training, resources, and consultation services. Visit the IU REDCap Knowledge Base for more details.
Training is available to help researchers build efficient REDCap databases. See the list of topics here.

Advarra eSource + EDC

Advarra eSource + EDC is available at https://ocr.iu.edu/what-are-research-systems/.
Advarra eSource + EDC is a 21 CFR Part 11 compliant system used for data collection and management, allowing researchers to collect data and manage it securely. It currently does not have survey capabilities, but these are scheduled for release in 2025. 
EDC is recommended for any FDA-regulated study wishing to collect data electronically where another Part 11 compliant platform is not provided.  The use of Biostatistics Data Management services is required to build data collection forms for your study and should be considered in your budget.

For cancer related research that involves outside institutions, databases must be built in such a way that prevents different institutions from viewing PHI data within the system.

For other databases, software, or data storage system requirements, please contact securemyresearch@iu.edu to ensure regulatory compliance and institutional approval.

IU Simon Comprehensive Cancer Center (IUSCCC) Additional Information

For new studies involving cancer or cancer patients, OnCore Forms EDC may also be an option for an EDC platform. Please reach out to the Cancer Center’s Protocol Development Team for more information at jsastre@iu.edu when deciding which EDC system to use for your database build.

- - OnCore is available at https://iuctsi-oncore-prod.forteresearchapps.com/forte-platform-web/login
  - OnCore may be used at IU to capture protected health information (PHI), and if used properly, is consistent with FDA 21 CFR Part 11 requirements.
  - OnCore can be used for capturing data for studies subject to FDA oversight. The Forms section of OnCore is available for this purpose.

If using Biostatistics for Cancer Center Research, complete the Biostatistics Service Request or contact Teresa Holland at tholland@iu.edu.

Contacts and Resources

Contacts

For assistance with Advarra EDC setup, contact the Biostatistics and Health Data Sciences Department: George Eckert at geckert@iu.edu or Jing Su at su1@iu.edu.
If using REDCap, visit https://indianactsi.org/researchers/recruitment-services/redcap/.

Resources

Building out your study database is only one component of study activation. Additional requirements should be reviewed using the Clinical Research Roadmap.