Regulatory Documents
Regulatory Documents (view by Category)
Simple table with project listing with progress and editing options. Upload new document(s).
| Type of Document | Complete? | Expires | Name | |
|---|---|---|---|---|
| 1572 (2) | Y | 2.28.19 |  FDA-1572 template 2018.02.27 |
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| 1572 (2) | Y | 6.3.18 | 1572 Signed 2018.03.02 |
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| Logs (11) | Y | 11.28.18 |  Delegation_of_Authority_Log_VTE MM Apix 1.0 Template |
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| Protocol (14) | N (86%) | 7.8.19 | Apixiban Protocol V 17.0 dated 2017.11.17 |
Delagation of Authority Log
| Role | Study Personnel | Sig. | Conduct Informed Consent Process |
Subject source documents completion/ correction |
Evaluate Inclusion/Exclusion Criteria & Medical History |
Determine WHO functional class |
IxRS records |
Perform Physical Examination |
Collect Laboratory Samples |
Perform Laboratory tests |
Perform Pregnancy Test |
Evaluate Lab tests results |
Perform Left hand X-ray |
Dispense/ Collect/ Accountability Study Medication |
Assess Adverse Events/ SAE reporting/ Device related events reporting |
ECG recording/ evaluation |
Echocardiogram procedure/ evaluation |
6-MWDT |
Tanner scale completion |
Child Health Questionnaire/ Taste assessment questionnaire ins... |
Complete/Correct CRFs |
Review/Sign CRFs |
Regulatory (including ISF maintenance, IRB Contact, etc.) |
Other – Please specify |
Start Date | PI Appr | End Date | PI Appr |
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Froehler, Michael, MD, PHD |  |
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03/31/18 |  |
03/31/18 | |
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Inactive Personnel
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