Table 2. Certification and Standardized Processes in the DCCT/EDIC Study.
| Procedure | Certification requirements | Standardized methods | Standardized equipment/ materials |
|---|---|---|---|
| Medical history / physical exam | Completion of data collection form on 2non-study participants | X | X |
| Blood pressure | Knowledge of study-specific measurement criteria | X | X |
| Data entry | Training module; entry and submission of “test” data form | X | X |
| Shipment of biosamples | Shipment of cold and frozen “test” samples | X | X |
| Visual acuity | Use of study-specific visual acuity techniques; training by local ophthalmology staff | X | X |
| Ophthalmology exam | Submission of curriculum vitae that documents ophthalmology expertise; knowledge of exam requirements and form completion | X | |
| Electrocardiogram | Paper submission of 2 “test” subject ECG’s to CERC; successful digital transmission of “test” ECG | X | X |