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completed, or the date that the records are no longer required for purposes of supporting a premarket approval application.
Patient Records
Each investigator is required to maintain complete, current and accurate records on each patient including:
- Documentation of relevant medical history
- Copies of completed case report forms
- Executed Informed Patient Consent
- Results of relevant diagnostic and laboratory tests
- Operative and Postoperative complications and treatment
- Other relevant information/documentation on the condition of the patient
Case Report Forms
For each patient in the study, the following case report forms and x-rays are to be completed and submitted per the following:
| CASE REPORT FORM/X-RAY | WHO RECEIVES | DEADLINE FOR SUBMISSION |
|---|---|---|
| Study Admission Checklist | Sponsor | 10 days from Date of Surgery |
| Informed Patient Consent | Sponsor, Patient | 10 Days from Date of Surgery |
| Patient Historical Profile | Sponsor | 10 Days from Date of Surgery |
| Operative Detail Form | Sponsor | 10 Days from Date of Surgery |
| Preoperative Hip Evaluation | Sponsor | 10 Days from Date of Surgery |
| Postoperative Hip Evaluation | Sponsor | 10 Days from Date of Examination |
| Radiographs | Sponsor | 10 Days from Date of x-ray |
| Radiographic Evaluation | Sponsor |
14 Days from Date of receipt of x-rays by
independent radiologist |
Rev. I
-000196
PROTECTED DOCUMENT. DOCUMENT SUBJECT TO PROTECTIVE ORDER.
DEPUY086224359
Source: https://www.industrydocuments.ucsf.edu/docs/tlxn0226
PLT-00725-00026