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Research Visits and Data Capture

ITHS › Investigators › Clinical Research Handbook › Conduct the Study › Research Visits and Data Capture

Research Visits and Data Capture

The key steps involved with research visits and corresponding data capture include the following:

Study Visits

Study Visits

Schedule and conduct study visits and research activities per the Institutional Review Board-approved protocol. Work with service providers and facilities to support intervention and data collection needs. If the patient is associated with a study budget in EPIC, then all study visits must be flagged in medical records.

Please see the Pre-Study Preparation sections for Industry-Sponsored and Investigator-Initiated research for details on processes related to:

  • Confirming Research Support Services/Facilities
  • Training/Credentialing
  • Research Instrument Validation and Calibration
  • Arranging Compensation for Research Participants
Data Capture

Data Capture

To complete Case Report Forms (CRFs), capture study visit documentation from participants’ medical records, and evaluation instruments and questionnaires. Enter study data into your data management system, which might be an electronic CRF or a custom database created in ITHS REDCap, Excel, or Access.

Please see the Pre-Study Preparation sections for Industry-Sponsored and Investigator-Initiated research for details on processes related to Creating a Study Database.

Specimens

Specimens

Many studies include collection and/or analysis of specimens, like blood, urine, and/or tissue. Be sure to follow both protocol and institutional requirements for collecting, processing, shipping, analysis, and storage of study specimens.

Please see the Pre-Study Preparation sections for Industry-Sponsored and Investigator-Initiated research for details on processes related to Bloodborne Pathogens Training and Shipping Biohazards Certification.