A Case Report Form (CRF) is used in clinical trials to track and report demographic and
medical information concerning study participants. This Sample Case Report Form may
be used as a template when creating a Case Report Form for a new study. This CRF
includes information about the inclusion criteria, the exclusion criteria, demographics,
initial screening, second visit, and final visit details. This CRF can be used by
individuals or entities that want to undertake a new study and want to track vital
information of study participants.
Case Report Form
Study Title: __________________________________
Date Informed Consent Form Signed ____________________
Inclusion Criteria Yes No*
*If any inclusion criteria are checked â€œno,â€ the patient is not eligible for the study.
Exclusion Criteria Yes* No
* If any exclusion criteria are checked â€œyes,â€ the patient is not eligible for the study.
Race: (check one)
____ American Indian or Alaskan Native
____ African American
____ Native Hawaiian or other Pacific Islander Ethnicity:
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Ethnicity: (check one) Gender: (check one)
____ Hispanic or Latino _____ Male
____ Non-Hispanic or Latino _____ Female
Date of Birth:_______________________ (mm/dd/yyyy)
Please enter all vital sign information using leading zeros as applicable.
Pulse rate: ___________ Bpm
Blood pressure: ___________/_____________ mmHg
Height: ______ ft. ______ in.
Weight: _____________ lbs.
Medications currently taking; (Include all prescription, non-prescriptions, and
Is there any relevant medical history in the following systems?
Code System *Yes No Code System *Yes No
1 Cardiovascular 9 Neoplasia
2 Respiratory 10 Neurological
3 Hepato-biliary 11 Psychological
4 Gastro-intestinal 12 Immunological
5 Genito-urinary 13 Dermatological
6 Endocrine 14 Allergies
7 Haematological 15 Eyes, ear, nose, throat
8 Musculo-skeletal 00 Other
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*If YES for any of the above, enter the code for each, give details (including dates), and state if
the condition is currently or potentially active. If giving details of surgery, please specify the
underlying cause. Use a separate line for each condition.
Code Details (including dates) Yes No