Your Easy Guide to Clinical Studies

In order to reduce potential input errors in the study database (eCRF), variables can be specified with additional technical constraints or edit checks.

 

Input constraints include:

• Format: Only allows input based on a pre-defined or standardised coding list, date format, lab value format (e.g. haemoglobin as g/l or g/dl)
• Range: Limit potential input based on an upper and lower limiting value
• Length: Limits input to a maximum of characters or number digits
• Branching: Some variable are only answered if a specific answer of a preceding question is selected (e.g. are you pregnant? Yes - addition questions)

 

Navigation options can reduce input errors:

• Selection: Multiple choice, drop-down menus, radio buttons facilitate and guide staff during data entry
• Support: Information provided to indicate how to fill in the related input field
• Warning message: displayed when:
  • Incorrect data is entered
  • Missing manatory data, value, or checkbox 

As a SP-INV, go through the list of selected study variables and for each variable define applicable technical requirements:

• Type of variable (e.g. direct input, single option, multiple options)
• Accepted range for numeric or date time variables
• Selective conditions (e.g. show or hide variables under certain conditions)
• Form name for each group of variables

 

In addition:

• Define the chronology and decide when a particular form must become visible for data to be entered (e.g. order of visits and collection)
• Select metadata standards for coding your data (e.g. CDISC, CTCAE)

 

For the database set-up:

• Define and document in collaboration with the data manager all technical requirements including its rational 
• Upon database set-up include a test-phase(s) to ensure planned specifications and its navigation are implemented as intended
• Upon the successful completion of the test-phase, confirm the release of the study database into the productive phase (e.g. input of real-life data)

 

A user-friendly and fit for purpose database (eCRF) will ensure that collected study data will be of high quality.

External Links

CDISC – Provides standards in the clinical research process

CTCAE – Common Terminology Criteria for Adverse Events

References

ICH GCP E6(R2) – see in particular guideline

• 5.5 Trial Management, data handling, and record-keeping