Source Data Recorded on the Case Report Form Sample Clauses

Source Data Recorded on the Case Report Form. All patient data must have supportive source documentation in the medical records, or equivalent, before they are transcribed onto the CRF. Data may not be recorded directly onto the CRF and considered as source data unless the study center obtains written documentation from ImmuPharma or its designee or its designee, prior to the beginning of the study, indicating which data are permitted to be recorded directly on to the CRF. Source documents, including test results and/or assessments (eg, clinical laboratory test results, ECG data and assessments, efficacy measurements) collected or performed by institutions outside of the study center, are retained by the study center (see section 13.2.1). The CRFs are filed in the ImmuPharma central file.
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