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CheckPad allows users to organize multiple studies in one system and reuse resources like CRFs and subjects among study.

Below is a simplified graph of a study within CheckPad with basic subjects in each study

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Case Report Form (CRFs)

  • CRFs are data entry forms designed to collect data for the purpose of the study
  • The studies in one systems can reuse each other's CRFs
  • CRF is only a data entry form and does not store the study's data

Subject

  • Subject are uniquely identified by Person ID
  • Subjects can be used among studies and is consistent in birth date and gender
  • Subjects in a particular study is called study subject

Study

  • CheckPad allows users to create one or many studies
  • Studies have different configurations and organization
  • Studies can reuse one another's CRFs and subjects

Study Subject

  • Study Subjects correspond to one subject in the system
  • If a subject does not exist in the system (no Person ID), subject creation process will simultaneously create a study subject and a corresponding subject
  • It the subject already exists in the system (Person ID exits in the system), subject creation process will reuse the date of birth and gender of the existing subject in the system to be consistent
  • Can configure CheckPad to not set Person ID so that subjects are not reused among studies

Visit

  • According to study protocol, a study subject will have their data collected in multiple visits
  • After each visit, there will be a number of Visit CRFs which needs to be filled in with gathered data
  • Each visit needs to be scheduled to enable data entry
  • Each visit has multiple statuses integrated from form statuses (read more on visit status)

Data entry form for each visit (Visit CRF)

  • Data entry forms for each visit CRF correspond to a single CRF in the system, and will collect the data specified in this CRF
  • Form is the smallest unit to display statuses such as data entry, SDV or sign (read more on visit CRF)

Data Field (Item)

  • An item is the smallest unit to collect information in a data entry form (visit CRF)
  • Each data field can have multiple functionalities (read more at CRF Builder)

Discrepancy Notes

  • Discrepancy notes are used in the system to mark discrepancies or add meaning to data fields of study subject, visit or forms
  • Discrepancy Notes can be used for multiple purposes and has multiple statuses (read more at Discrepancy Notes)