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Activase Cathflo Investigator Brochure Version:19-Sep-2013

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2011-09-26 19:54:22
851.34 KB
4787
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Acknowledgement of Receipt for Investigator Brochure Version:19-Sep-2013

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2011-09-26 19:54:22
27.5 KB
3920
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Statement of Agreement on Investigator Responsibilities

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2011-09-26 19:54:22
49.72 KB
3376
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Adaptive Randomzation Recommendation for CLEAR-III

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Report from Hopkins Biostatistics recommending implementation of an adaptive trial design for randomization patients in CLEAR-III.





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2011-09-26 19:54:22
190.95 KB
3274
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CLEAR-III Adaptive Randomization - Letter to Site IRBs

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2011-09-26 19:54:22
63.34 KB
3422
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CLEAR-III IRB Submission FAQs

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IND# and similar information to support local IRB applications.





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2011-09-26 19:54:22
28 KB
3361
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FDA Form 1572 Version:May08

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2011-09-26 19:54:22
51 KB
3528
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Delegation and Site Signature Log for CLEAR-III

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To be completed and signed by principal investigator listing all staff and their designated responsibilities.





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2011-09-26 19:54:22
34.5 KB
3377
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IND Acceptance Letter Version:28-Jul-99

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Letter from US FDA acknowledging receipt of Investigational New Drug Application from Daniel F. Hanley (sponsor) for Tissue Plasminogen Activator (TPA) used in hemorrhagic stroke





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2011-09-26 19:54:22
92.88 KB
3593
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NINDS Research Submission for CLEAR-III Version:05-Jul-2008

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NINDs Grant





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2011-09-26 19:54:22
1.43 MB
5126
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NINDS Notice of Grant Award (NGA) for CLEAR-III

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2011-09-26 19:54:22
59.28 KB
3339
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FDA 1572 Version 2/29/2012 Version:CLEAR-III Template

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This is an updated version of the the FDA 1572 form. The FDA still lists both versions of the form on their website and either is acceptable. 





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2012-04-05 15:28:12
1.15 MB
3620
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