This database is designed for the input and verification of data from investigator-initiated trials. The computerized forms mimic the paper forms used for input of data from research subjects and make data entry easier than just spreadsheet input. Forms can be immediately printed with certification notation for documentation requirements.
Data validation measures are incorporated with the triggering of computerized “flags” when the data is out-of-range and adverse event reporting is necessary.
All forms are easily accessed at any time as are subject-specific comments made by the site personnel or the Principal Investigator.
Multiple types of counts to check the “location within the study” are available. Reports can be printed which indicate specific information for all subjects.
C.R.I.E.R. ™ differs from C.R.I.E.R.-Lite ™ in the number of forms and complexity of the data input measures, especially the labs, which indicate out-of-range values for each measured value. In these cases, these can be noted as “not clinically significant” or as “clinically significant,” in which case the user is automatically sent to the Adverse Experience form. Included labs are Chemistry, Hematology, Urinalysis, Histopathology and Microbiology. Others can be developed as needed.