med. Dr. rer.
med. Investigator’s File 1 16 Sep 13 Associated Forms And Templates: 109.5 MED. 01 Investigator´s File Table of Content 1 16 Sep 13 109.5 MED. Electronic Study Folder and Shadow File 109.7 MED.01 Shadow File Coordinators Log 109.7 MED.02 Electronic Folder Names 109.7 MED.03 Example of Electronic Study Folder and Shadow File Structure 1 1 1 1 16 Sep 13 16 Sep 13 16 Sep 13 16 Sep 13 110.1 MED. Clinical Supplies 3 16 Sep 13 Associated Forms And Templates: 110.1 MED. 01 Temperature Log 3 16 Sep 13 110.1 MED. 02 Clinical Supply Shipment Management Log 3 16 Sep 13 110.1 MED. 03 Clinical Supply Accountability Form 3 16 Sep 13 110.1 MED. 04 Re-labelling Report 3 16 Sep 13 110.1 MED. 05 Investigational product RECALL form 3 16 Sep 13 110.1 MED. 06 Investigational product RETURN form 3 16 Sep 13 110.1 MED. 07 Clinical Supply Destruction Report 110.1 MED.08 Site Investigational Product Accountability Log 3 1 16 Sep 13 16 Sep 13 111.1 MED. Clinical Trial Materials 2 30 Sep 13 Associated Forms And Templates: 111.1 MED.01 Trial Supply Shipment Form 4 30 Sep 13 111.1 MED.02 Controlled Copy Distribution Log 3 30 Sep 13 111.1 MED.03 Frozen Samples storage log 3 30 Sep 13 111.1 MED.04 Investigator’s Brochure Acknowledgement of Receipt 2 30 Sep 13 VBL Confidential Information Page 1 of 64 Version 2.2 02 DEC 2013 Portions of this exhibit have been omitted and filed separately with the SEC pursuant to a confidential treatment request and are indicated by [***]. 112.1 MED. Serious Adverse Event Reporting 3 08 Mar 13 Associated Forms And Templates: 112.1 MED. 01 SAE Pregnancy Report Form 3 08 Mar 13 112.2 MED. Distribution of SUSAR reports 2 15 Sep 11 Associated Forms And Templates: 112.2 MED. 01 SUSAR Reports Tracking Log 2 15 Sep 11 112.5 MED. Safety Management Principles 1 16 Sep 2013
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med dent. and Dr. rer. medic. you need at least one additional su- pervising person in addition to the first supervisor. For the degrees PhD and MD/PhD you will need two additional supervisors. The first supervisor should be a member of the Charité. If this is not the case (e.g. for members of the FU or HU), another supervisor must be a member of the Charité. We have listed on our website who may supervise doctoral projects [in German only]: xxxxx://xxxxx- xxxx.xxxxxxx.xx/xxxxxxxxxxxxxxxxxxx/xxxxxxxxx/ □ Section A/ The Work: o Please try to present the topic of your work as precisely and as meaningful as possible! o Clarify with your supervisors whether you need an animal experiment permit or an ethics vote or both! Note: If you are aiming for a publication doctorate, please note that some journals also require an ethics vote for works that do not require one under German law. o Provide meaningful information on the sub-steps and investigations! o Provide a realistic and meaningful processing time. For example, do not write "6 months" if you want to conduct a study with patients that is planned to last several years! □ Section B: Please make sure that the information on the methods already established and those yet to be established are meaningful! □ Obtain all signatures of your supervisors! Please also sign yourself! Have your first supervisor also stamp the agreement! Without stamp and signatures we cannot register you! □ Further information (p. 9): Fill in this section completely! Download the key directories (Schlüsselver- zeichnisse), which will help you answer the questions: xxxxx://xxxxxxxxx.xxxxxxx.xx/en/links_down- loads/ □ Annexes (p. 11): Please ensure that you attach all the required annexes (simple copy attached). □ If you present your Bachelor's and Master's certificates, please make sure that the number of ECTS credit points is also shown! For a BA you must have acquired at least 180 ECTS credit points, for a Master at least 120 ECTS credit points. If you have acquired less than 300 ECTS credit points, you must go through an aptitude assessment procedure, which is, however, subject to certain conditions: xxxxx://xxxxxxxxx.xxxxxxx.xx/en/procedure/regulations_2017/aptitude_assessment/ If you have ac- quired a foreign university degree, please read our notes on this carefully: xxxxx://xxxxxxxxx.xxxx- xxx.xx/xx/xxxxxxxxx/xxxxxxxxxxx_xx_xxxxxxxxxxxxx_xxxxxxx/ Thanks a lot! Your Doctoral Office Medical Faculty Charité – Universitätsmedizin Berlin Cam...
med. X’s Marks and Trademarks and the intellectual property rights to these Marks, and their registrations, if any, shall at all times be the sole property of MED-X and ENSYSTEX recognises MED- X’s sole right of ownership and interest herein. ENSYSTEX shall never challenge nor attempt to weaken any part of MED-X’s right, ownership or interest in the Marks whether registered or not. ENSYSTEX shall not be entitled in any way to claim that they own such Marks or their registrations, and ENSYSTEX recognises that any use of such Marks by ENSYSTEX, and as approved by MED-X, shall not give ENSYSTEX any right, ownership nor interest in such Marks.
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med. 105.1 MED. 10 Follow-up Site Initiation Visit Letter 105.1 MED. 11 Financial Disclosure Form 105.1 MED. 12 Subject pre-screening Log 105.1 MED. 13 Site Initiation Visit Agenda 2 2 2 2 04 Mar 11 04 Mar 11 04 Mar 11 22 Jan 13 105.1 MED. 14 List of Site Initiation Visit Activities 1 04 Mar 11 105.1 MED. 15 Consent to Processing Personal Data 1 02 Jun 11 105.1 MED. 16 Instruction on How to Manage Consent for Personal Data in Clinical Operation Department 1 27 Aug 12 106.1 MED. Monitoring Visit 2 18 Apr 11 Associated Forms And Templates: 106.1 MED. 01 Confirmation Monitoring Visit Letter 2 18 Apr 11 106.1 MED. 02 Monitoring Visit Report 3 18 Apr 11 106.1 MED. 03 Contact Report 2 18 Apr 11 106.1 MED. 04 Subject Visit Status 2 18 Apr 11 106.1 MED. 05 Note to File 3 18 Apr 11 106.1 MED. 06 Follow-up Monitoring Visit Letter 2 18 Apr 11 106.1 MED. 07 Monitoring Visit and Reporting Plan 2 18 Apr 11 106.1 MED. 08 Data Clarification Form 106.1 MED. 09 Site Personal Training Log 106.1 MED. 10 Confidentiality Violation Log 1 1 1 18 Jul 11 26 Jun 12 26 Jun 12 106.2 MED. Taking Over The Study 3 31 May 13 Associated Forms And Templates: 106.2 MED. 01 CRA Site Take-Over Checklist 5 31 May 13 106.2 MED. 02 CTA Take-Over Checklist 2 31 May 13 106.3 MED. Co-Monitoring Visit 2 25 Jul 11 106.3 MED. 02 Co-monitoring Visit Report: Quality Control Assessment 2 25 Jul 11 106.4 MED. Reporting Protocol Deviations 2 10Aug10 Associated Forms And Templates: 106.4 MED. 01 Protocol deviation report 106.4 MED. 02 Protocol Deviation Cumulative List 2 1 10Aug10 10Aug10 VBL Confidential Information Page 1 of 64 Version 2.2 02 DEC 2013 Portions of this exhibit have been omitted and filed separately with the SEC pursuant to a confidential treatment request and are indicated by [***].
med agrees to post an overtime list.
