Standard operating procedures

The Clinical Trials Research Unit runs studies and trials according to the standard operating procedures listed below.

On

If you would like access to any of the standard operating procedures, contact the QA team at ctruqa@sheffield.ac.uk.

General

Shef/CTRU/GEN001 SOP requirements for non-CTRU statisticians, health economists and modellers
Shef/CTRU/GEN002 SOP Management
Shef/CTRU/GEN003 Training Records and Staff Training
Shef/CTRU/GEN004 Quality Checking of Study Outputs

Data management

Shef/CTRU/DM001 Data Protection
Shef/CTRU/DM003 Case Report Form Development
Shef/CTRU/DM004 Study Database Development
Shef/CTRU/DM005 Central Data Validation
Shef/CTRU/DM006 Data Entry and Import
Shef/CTRU/DM009 Data Management Plan
Shef/CTRU/DM012 Study Database Lock and Retention
Shef/CTRU/DM015 Data Sharing

Prospect

We can provide expertise in data management and database design. Using Prospect, our in-house web-based electronic data capture system, we will work with you to design a bespoke database to allow you to meet your data collection and management needs.

Prospect is designed specifically to support remote data input for clinical studies. It provides user-friendly data collection with validation features to promote high-quality data and allows for comprehensive privilege management, enabling custom access control on a per-user basis. The system also incorporates a user activity log and a data audit trail.

For more information, email us at ctru-dm-group@sheffield.ac.uk.