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Delegation of Responsibility Log Version:v.08242015

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Blank Delegation of Responsibility Log for completion by MISTIE-III clinical sites.  The names listed here should match both the FDA-1572 and the staff document tabs in the EDC.





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2013-08-03 11:59:03
45.5 KB
3898
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Required regulatory & training document Listing Version:v4-10142013

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Grid showing the regulatory documents and training certificates required of MISTIE-III staff based on their delegated responsibilities at a clinical site.





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2013-08-03 12:03:53
44.46 KB
4264
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EDC Electronic Signature & Patient Health Information Agreement Version:26Jun2015

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This agreement must be signed prior to obtaining a password to the MISTIE-III Electronic Data Capture (EDC) system. It describes obligations relating to confidentiality and electronic signatures.





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2013-08-27 13:25:00
107.94 KB
3139
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MISTIE-III Certificate of Training on Dosing

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Anyone administering the study drug must undergo training. This may consist of taking the online course in Emissary College, or alternatively the Principal Investigator may personally train an individual that is otherwise authorized by the institution to administer intrathecal drugs. This certificate is provided to document such training. It should be signed by the trainee and the principal investigator then uploaded to the eTMF on a staff tab labeled for the trainee. This person will then appear in the drop-down selector within the EDC system when entering dosing details.





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2013-09-26 22:23:15
78.58 KB
3186
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MISTIE-III Site Expectations and Investigator Agreement

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2015-04-20 13:11:54
53.64 KB
1914
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MTI-M3 Sample Tracking Sheet Version:Feb2016

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2016-02-25 12:19:57
257.02 KB
1765
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