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Site Personnel Directory

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Site Personnel Directory (Blank)





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2012-03-22 12:09:30
74 KB
3726
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CLEAR-III Concomitant Medication List (PDF) Version:v7

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This is a searchable PDF listing of the concomitant medication dictionary used in the CLEAR-III trial. It is useful for searching for generic names and classification categories when entering drugs into the EDC system.





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2011-09-26 19:54:22
90.11 KB
5335
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Electronic Signature and Patient Health Info Agreement

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This agreement must be signed by anyone needing access to the VISION EDC online case form.





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2011-09-26 19:54:22
138 KB
4649
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Instructions for uploading Modified Rankin Videos in CLEAR-III

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2011-09-26 19:54:22
170.26 KB
3685
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CLEAR-III Required Site Document List

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2011-09-26 19:54:22
54 KB
3893
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CLEAR-III Flush Guideline

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2011-09-26 19:54:22
89.32 KB
4656
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CLEAR-III Extended Glasgow Outcome Scale Guideline

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2011-09-26 19:54:22
13 B
3304
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BIOS Policy on Patient Privacy

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2011-09-26 19:54:22
334.32 KB
5618
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CLEAR-III Conditions + Procedures + Adverse Event Dictionary Version:v8

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2011-09-26 19:54:22
626.26 KB
7717
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CLEAR-III Dosing Time Planning Guide

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2011-09-26 19:54:22
91.39 KB
4490
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VISION EDC Users Guide

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2011-09-26 19:54:22
1.65 MB
3691
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CLEAR-III Sample Grab & Go Enrollment Packet

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2011-09-26 19:54:22
1.87 MB
4008
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ctcae_29may09_v4.0_meddra_v10_bios_10mar10_v6

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2011-09-26 19:54:22
391 KB
3917
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ctcae_29may09_v4.0___meddra_v10__bios_10mar10_v6

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2011-09-26 19:54:22
716.82 KB
3939
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CLEAR-III On Call Schedule Version:1.0

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This is the CLEAR-III On Call Pager Schedule from November 2011 to March 2012. 





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2011-11-23 13:47:53
13.49 KB
3115
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CLEAR-III Pager On-Call List Version:Nov11

(0 votes)

Excel document showing which BIOS staff member is carrying the 24-hour study pager on a specific date.





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2011-11-30 16:13:10
13.49 KB
3153
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Financial Disclosure Form Version:1.0

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This is the standard Financial Disclosure form for CLEAR-III and is required for the PI, SC, any Sub-Investigator or Coordinator listed in section 6 of your Site's FDA-1572.





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2011-12-22 15:51:54
30 KB
3663
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CLEAR3 - Excluded Med Time Windows Version:11-May-12

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Graphic showing the allowed and excluded medications in the CLEAR III trial and the time window over which they are disallowed. Medications mentioned:  aspirin, dabigatran / Pradaxa®, clopidogrel / Plavix®, warfarin / Coumadin®, low molecular weight heparins (enoxaparin/Lovenox®, dalteparin/Fragmin®, etc.), heparin, rtPA (alteplase, retiplase), urokinase, desmoteplase, and streptokinase.

New to protocol v3: During dosing, study center standard of care policies may govern the use of DVT prophylaxis. In the green area note the allowable use of unfractionated heparins for DVT prophylaxis during the acute treatment and follow-up periods. Heparin flushes of systemic lines are also permitted. Please, if your must flush the IVC, use only normal saline flushes. Please do not administer any thrombolytic agent through any IVC. These agents include urokinase, retiplase, desmotoplase, and rt-PA.

In the red area, note there are certain drugs that are not permitted during the study article administration.

During dosing, please do not use low molecular weight heparins. You may start low molecular weight heparins a full 72 hours after the last dose of test article. When doing so, please limit to less than 30 mg per day.

Further prohibited drugs include all antithrombotic agents, antiplatelet agents, Glycoprotein IIb/IIIa inhibitors, ASA, Clopidogrel/Plavix, Warfarin. Withhold these drugs until after the 30-day follow-up visit.

Avoid enoxaparin at high doses (that is, greater than 30 mg per day) until the subject completes the study.The second page of this PDF shows the medical events being closely monitored for any potential increase in bleeding risk that are the reasons for these exclusions (as they would confound that determination).





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2012-02-06 14:56:11
59.85 KB
4230
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Dosing Management Laminated Card

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This is provided to sites as a laminated card to show how long to hold randomization/dosing for various events.  The back-side is the schedule of events.





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2012-04-11 17:54:16
201.01 KB
3913
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Aspiration and Flush Laminated Card

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This wallet-sized card is laminated and provided to the sites at start-up. The graphic is included here in-case additional cards need to be printed at the site.





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2012-04-12 11:49:37
22.18 KB
3634
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CLEAR Contacts - laminated pocket card

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This wallet-sized card is provided to new sites upon initiation. It shows the contact information of the BIOS support team at Johns Hopkins for the CLEAR III clinical trial. Sites should contact BIOS when enrolling a new patient.





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2012-04-12 11:55:55
193.96 KB
3323
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CLEAR schedule and stopping rules - laminated card

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This 2-sided full-page document is provided to new sites as a laminated card. It shows the study schedule of events and gives the rules for when to stop the q8 hour test article administration.





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2012-04-12 13:42:08
824.59 KB
3857
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CLEAR laminated card on inclusion/exclusion criteria

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This graphic is laminated and provided to new sites as a handy reference on the CLEAR trial inclusion/exclusion criteria.





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2012-04-12 13:44:58
222.05 KB
4477
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Site Fact Form Version:1.0

(0 votes)

Blank site fact form for new sites. 





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2012-05-23 16:20:46
122 KB
3662
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ISC 2013 CLEAR Annual Meeting And Reception Invitation

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2012-12-14 14:30:51
271.14 KB
3708
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