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Study start up

 STUDY START UP/STUDY SET UP:

eCRF(case report form):

The case report form is a printed or electronic questionnaire for collecting data from study participants and reporting it to trial sponsors. The document is created specifically for each research project in accordance with

  • the trial protocol, and

  • recommendations of the Clinical Data Acquisitions Standards Harmonization (CDASH). They are developed by Clinical Data Interchange Standards Consortium to streamline industry-wide data exchange. Say, CDASH dictates dd/mm/yy format for collecting dates. (Read our article on CDISC standards to learn more.)

Well-designed case report forms collect only data necessary for the particular study avoiding any redundancy. The fields to be filled in may include

  • demographics (age, gender),

  • basic measurements (height, weight),

  • vital signs (blood pressure, temperature, etc.) captured at various time points,

  • lab exams,

  • medical history,

  • adverse events, and

  • more, based on the research requirements.

Data managers create data entry screens and eCRF layouts in collaboration with a database programmer. The design usually goes through several review cycles before finalization.

  •  Crf pfd

  •  Compare crf pdf with protocol

  • eCRF specification-prepare

  • Explain ecrf spec to programmer

  • Draft ecrf Review,updates and changes

  • Final ecrf

  • Ecrf in EDC(electronic data management)

  • Compare ecrf spec with EDC

        EDIT CHECK DOCUMENT:  

                Edit check document

  • Edit check specification

  • Manual query and automated query

  • Dynamics 

  • Populate a query in edc

  • Provide edit check specification parallel with ecrf specification to programmer

  • Compare edit check specifications with edc

       UAT(user acceptance testing): 

  •  Role testing: testing role for team members like access

  • Screen testing

  • Structural functionality

  • Edit checks

  • Any of the data which falls out of range it should populate a query and for any thing which falls within a range that it express should not populate a query

  • LAB values-enter in UAT

  • Sponsor DM—CRO DM—LNR(lower normal range) template—Lead CRA(site)---Fill(template)---CRO CM—EDC —---manual,automated 

  •  eCRF completion guidelines

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