Case Report Forms (CRF)

Large orders or small orders, MPI pays attention to each detail of customers’ specifications, from order entry through inspection and delivery. Our workmanship is guaranteed.

  • Any configuration of carbonless paper
  • Optional “hard” last page
  • Perforated stubs
  • Any hole drilling configuration
  • Edge glued on side or top
  • Customized index tabs
  • Drop/ship to investigation sites
  • Precision collating
  • Multitude of binder colors and sizes
  • No charge CRF consulting service
  • Complete “in-house” production facility
  • Price quotes given on the phone and verified via email
  • Confidentiality respected

CASE REPORT FORM (CRF) DESCRIPTION

Case record form is a paper or electronic document designed to record all the information for an individual study subject required by the Study protocol.

The Case record form is used for several purposes:

  • to ensure data collection in accordance with the Study protocol;
  • to ensure fulfilling of the regulatory authorities’ requirements for data collection;
  • to facilitate the effective, comprehensive data processing and analysis, results reporting, and to promote the safety data sharing between the study team and other departments of the institution.

The data collected in the study site during the course of a study should be comprehensive and provide true and fair information on what happened to each study subject. Only if the above criteria are met, the study will reliably answer the questions concerning the efficacy and safety of the investigational drug.

All CRF’s should include the following data:

  • study title and number;
  • Investigator’s name;
  • study subject/patient ID (number and initials);
  • inclusion / exclusion criteria;
  • demographic data;
  • detailed description of dosage regimens of investigational drug;
  • concomitant treatment;
  • adverse events (side effects and intercurrent diseases);
  • conclusion on subject’s health;
  • Investigator’s signature and date.

Additionally, the CRF’s should include special pages to record the following information:

  • past medical history;
  • results of physical examination;
  • primary and secondary diagnoses;
  • relevant previous treatment;
  • baseline characteristics, results of interim assessments, evaluation of efficacy endpoints, laboratory tests, description of study procedures etc.