CHANGE OF MONITOR AT STUDY SITE No: CM Effective Date: 15 April 2013 Version Date: 15 March 2013

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2 CONTENTS: 1. DEFINITIONS/REFERENCES PURPOSE SCOPE RESPONSABILITIES PROCEDURES Assessment of Need and Approval of Change of CRA Project training Documentation of Handover RELATED SOPs and GUDELINES.3. APPENDICES/FORMS/SUPPORTING DOCUMENTS Appendix 1 Main Procedural Differences from Previous Version Appendix 2 Form FCM.8-001Change of CRA Authorization Appendix 3 Form FCM.8-002Clinical Staff Project Training checklists Page 1 of 7

3 1. DEFINITIONS/REFERENCES Clinical Research Associate (CRA): An appropriately-trained and qualified individual appointed by Altiora to be responsible for trial site monitoring. Their duties include ensuring that all required study documents and materials are present and that the investigator and study staffs are adequately informed of the study procedures and requirements. Trial site: The location(s) where trial-related activities are actually conducted (ICH GCP section 1.59). Investigator: A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator (ICH GCP 1.34). Investigator : a doctor or a person following a profession agreed in the Member State for investigations because of the scientific background and the experience in patient care it requires. The investigator is responsible for the conduct of a clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the leader responsible for the team and may be called the principal investigator; ( DIRECTIVE 2001/20/EC) The investigator(s) should be qualified by education, training, and experience to assume responsibility for the proper conduct of the trial, should meet all the qualifications specified by the applicable regulatory requirement(s), and should provide evidence of such qualifications through up to date curriculum vitae and/or other relevant documentation requested by the sponsor, the IRB/IEC, and/or the regulatory authority(s). (ICH GCP section 4.1) Project team: The project team consists of the full-time and part-time resources assigned to work on the deliverables of the project all of who will help achieve the project objectives. For the purpose of this SOP project team is presented by the person appointed either by Altiora or the Sponsor who is responsible for study performance. Sponsor: An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial. (ICH GCP section 1.53) 2. PURPOSE To define procedures for identifying and notifying Sponsor of a change of monitoring personnel for a particular study site. This procedure includes the documentation of project training and transfer of monitoring responsibilities to the new CRA. 3. SCOPE Applies to Clinical Operations Staff within Altiora. It begins with identification of the need to change a CRA and ends with documentation of appropriate training and transfer of responsibilities. 4. RESPONSIBILITIES Responsible Manager (Manager): In discussion with project team members, determines the need for a change of CRA and authorizes the change. Approves the change of CRA Page 2 of 7

4 and informs the Sponsor. May identify the need for a change of CRA. Undertakes or supervises the training of the new CRA. 5. PROCEDURES 5.1 Assessment of Need and Approval of Change of CRA The Manager decides, or is made aware by a project team member, that a change of Study CRA is required at a study site. The Manager discusses need for replacement and proposed staffing solutions with current CRA and decides whether or not a replacement is required. When a replacement is necessary, the Manager identifies potential replacement CRAs nominates one of them to the vacant position The Manager signs a Change of CRA Authorization or equivalent form, having checked that study details have been added to it and that the personnel listed on it have been informed of the change. 5.2 Project training The new CRA familiarizes herself/himself with site specific sections of the Central Clinical Study File. The new CRA, current CRA, and the Manager or designate discuss site status and issues. The current CRA or designate carries out project training (as necessary) and provides the new CRA with all current study documents. Where possible, the new CRA and current CRA carry out a co-monitoring visit, to include introductions to the Investigator and support staff. 5.3 Documentation of Handover The Manager or designate completes the Clinical Staff Project Training checklists or equivalent, attaching a narrative, if required. The new CRA and current CRA or Manager sign and date the checklist, which is then approved, signed and dated by the Manager. Handover documentation should be filed in the Central Clinical Study File with Site Visit Reports. A copy of the Clinical Staff Project Training Checklist should be filed in the new CRA s Staff Record/Training file. 6. RELATED SOPs and GUDELINES NONE APPENDICES/FORMS/SUPPORTING DOCUMENTS Appendix 1 Main Procedural Differences from Previous Version Appendix 2 Form FCM.8-001Change of CRA Authorization Appendix 3 Form FCM.8-002Clinical Staff Project Training checklists Page 3 of 7

5 APPENDIX 1 Page 4 of 7

6 MAIN PROCEDURAL DIFFERENCES FROM THE PREVIOUS VERSION SOP # MODIFICATION Version Date CM DIRECTIVE 2001/20/EC Investigator definition added 17 March 2010 ICH GCP Sponsor definition added CM None 15 March 2013 Page 5 of 7

7 APPENDIX 2 Page 6 of 7

8 CHANGE OF MONITOR AUTHORISATION FORM FCM CHANGE OF MONITOR AUTHOIZATION Protocol Number: Sponsor: Manager: Proposed Change of Staff: To come off study:... To go onto study:... Date of change:..... Reason for proposed change: (Sponsor requirement, career progression, incapacity, leaving Altiora, another study, geography, sharing sites etc.) Brief history of study and overall progress: Who will inform Sponsor and when?:...(name)... (date) Change of Monitor authorized by Responsible Manager/equivalent: Signature:... Date:... Page 1 of 1

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10 CLINICAL STAFF PROJECT TRAINING FCM CLINICAL STAFF PROJECT TRAINING PART 1: IN-HOUSE Protocol Number: Investigator: Sponsor: Site Number: Sponsor/ALTIORA staff present: Sponsor Current Monitor New Monitor Other Specify: Date(s) of training: Have the following been discussed and reviewed: Product/therapeutic area YES NO NA Protocol Clinical Monitoring Plan CRF content/annotations Data Management Central Clinical Study File Project status/targets Site recruitment status Adverse events Laboratory Investigational Product/Device Communication pathways Finance Relevant SOPs/forms Study-specific items Regulatory issues/status Outstanding issues Comments: Page 1 of 2

11 CLINICAL STAFF PROJECT TRAINING FCM PART 2: ON-SITE Co-monitoring visit performed: Comment if not performed: YES NO DATE: Sponsor/ALTIORA staff present: Sponsor Current Monitor New Monitor Other Specify: Date(s) of training: Have the following been completed: YES NO NA Introduction to site staff Visit to facilities Visit to pharmacy/study drug storage area Visit to laboratory Source document familiarization Investigator's File familiarization Optimal time for contacts/visits Other specify bellow: Comments: Project training completed: Name Signature Date Current Monitor:.. New Monitor: Other (if applicable): Responsible Manager (for approval).. Page 2 of 2