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2 Page 2 (9) CONTENTS 1. PURPOSE DEFINITIONS RESPONSIBILITY INVESTIGATOR SELECTION Identification of Investigator s Initial Contacts Distribution of Pre-Study Documents PRE-STUDY VISIT(s) Conducting the Visit Information about the study Investigators Responsibilities and Obligations Qualifications and Curriculum Vitae (CV) Time and resources Facilities and equipment Investigational Product Laboratory (if applicable) Other Departments (if applicable) Financial Agreement Financial Disclosure edc studies Documenting the Visit Pre-Study Report Issues Review Filing Follow up with the Investigator Clinical Site Agreement SITE SELECTION... 8

3 Page 3 (9) 1. PURPOSE This (SOP) defines company policy and procedures to be followed during the planning phase of a clinical trial. Included are the search for and selection of investigators, Pre-Study Visits and a checklist of Pre-Study Documentation. This SOP is valid for all clinical pre-study Activities performed by TFS monitors. 2. DEFINITIONS 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. (Reference: ICH E6 GCP 1.34) Sub-investigator Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g. associates, residents, research fellows). (Reference: ICH E6 GCP 1.56) Coordinating investigator An investigator assigned the responsibility for the coordination of investigators at different centres participating in a multicentre trial. (Reference: ICH E6 GCP 1.19) 3. RESPONSIBILITY Monitor Responsible for 4. INVESTIGATOR SELECTION 4.1 Identification of Investigator s Before looking for potential investigators for a new study the sponsor should be contacted to determine whether or not they have already identified any potential investigators. Investigators can be identified in a number of different ways including literature and internet searches, previous contacts, investigators who have already been identified during a feasibility study and investigators who have already worked on similar studies managed by TFS. Before contacting investigators it should be verified that they are not registered on any black lists such as the FDA s.

4 Page 4 (9) 4.2 Initial Contacts Initial contacts with investigators will be made by telephone, face to face meeting or mail. The initial information provided to the investigator will be limited so as not to reveal confidential information but should normally contain the following information: A brief description of the project, the investigational product and the rationale for the study A brief description of the study design, the number and type of subjects, the duration of treatment and the assessments required The time schedule for the study The type of drug The time frame to obtain a reply from the physician about his interest in conducting the study Initial contacts will be documented in writing using the Contact Report. Contact Reports with investigator(s) will be included in the Study Master File. 4.3 Distribution of Pre-Study Documents When a potential investigator has expressed interest in conducting the study he should be provided with suitable study related documents in order to be able to form an opinion as to whether he can participate in the study. Suitable documents to send to the investigator are; Synopsis Draft clinical study protocol Investigator s brochure Before sending any study related documents to the investigator the monitor should first obtain a signed Confidentiality Agreement from the investigator (a photocopy or scanned copy is acceptable). Two original Confidentiality Agreements should be signed. One original should be filed in the Study Master File and one should be filed in the Investigator s File. Distribution of protocols and Investigator s Brochures should be documented using the Document Transmittal form list unless otherwise agreed with the sponsor. 5. PRE-STUDY VISIT(s) After the potential principal investigator has reviewed the study protocol, a pre-study visit will be held at the potential study site. If the investigator is known to TFS and has recently worked on a similar study a pre-study visit may not be necessary, if the procedures required in the SOP can be complied with by other means, such as, by telephone, and post. The decision not to perform a pre-study visit for a particular investigator will be made by the project leader in agreement with the sponsor. The aim of the pre-study visit is to verify the potential investigator s interest in and capacity to participate in the study by assessing that the investigator has:

5 Page 5 (9) Adequate training and experience including Good Clinical Practice Access to the subject/patient population Adequate resources and qualified site personnel to conduct the study Adequate site facilities and study specific equipment Sufficient time to conduct the study That the investigator can and has the capacity to include sufficient patients as defined in the study protocol 5.1 Conducting the Visit During the visit the monitor should perform the following tasks. This may be at a separate meeting before the study start Information about the study The monitor will discuss the Clinical Study Protocol and Investigational Product in detail with the Investigator and establish that the investigator has a potential for recruiting the required number of suitable subjects within the agreed recruitment period. This assessment can be based on retrospective data Investigators Responsibilities and Obligations The monitor will ensure that the investigator is aware of his responsibilities and obligations as defined in ICH GCP Guidelines and local regulatory requirements. At some time before the start of the study all items on the pre-study report form should be checked or reviewed with the investigator Qualifications and Curriculum Vitae (CV) The monitor will ensure that the investigator has adequate qualifications to conduct the trial as defined in ICH GCP guidelines. Investigators 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 an up-to-date curriculum vitae and/or other relevant documentation requested by the sponsor, the IRB/IEC, and/or the regulatory authority(ies). (Reference: ICH E6 GCP 4.1.1) Be aware of, and should comply with, GCP and the applicable regulatory requirements. (Reference: ICH E6 GCP 4.1.3)

6 Page 6 (9) The investigators qualifications and education should be adequately documented in a CV which should be collected before the initiation visit. The CV should preferably be written in English and must be less than one year old and signed and dated by the investigator. The CV template for Study Site Personnel can be used for this. A CV will also be collected for all study site personnel who have important duties in the study and are listed on the signature and delegation list e.g. sub-investigator(s) and study nurse(s) Time and resources The monitor will establish that the investigator has sufficient time to properly conduct and complete the trial within the agreed trial period. It will also be verified that the study site has adequate resources in the form of qualified staff to be able to perform the study in accordance with the clinical study protocol. If necessary, the monitor will discuss the possible need for involvement of additional investigators and other study team members Facilities and equipment The monitor will ensure that there are adequate facilities and equipment to properly conduct the study in accordance with ICH GCP guidelines and the study protocol. If the study requires specific equipment such as blood pressure manometers and ECG apparatus the monitor will ensure that they are validated and calibrated Investigational Product The monitor will ensure that the investigator has adequate facilities and procedures to adequately manage the handling and storage of the investigational product. Where the investigator decides to assign responsibility for investigational products to a pharmacy or other appropriate individual this should be documented. If it has been decided that the pharmacy will be responsible for destruction of clinical supplies then the monitor should ensure that adequate procedures are in place. If not covered by the Confidentiality Agreement with the Investigator a Confidentiality Agreement shall be obtained before any confidential study specific details are discussed Laboratory (if applicable) When a laboratory at the investigational site will be used for analysing samples the monitor will check that there are adequate procedures in place and ensure that the laboratory is accredited for the analyses to be performed for the study. Before the initiation of the study the monitor will discuss the routines for handling, labelling and shipping of samples for the study and will collect a copy of the accreditation and laboratory normal ranges for the selected tests to be analysed for the study.

7 Page 7 (9) If not covered by the Confidentiality Agreement with the Investigator a Confidentiality Agreement shall be obtained before any confidential study specific details are discussed Other Departments (if applicable) When other departments are involved in the study, e.g. radiology, the monitor should visit these departments in order to discuss their role in the study and to discuss or explain any study specific procedures. If not covered by the Confidentiality Agreement with the Investigator a Confidentiality Agreement shall be obtained before any confidential study specific details are discussed Financial Agreement The monitor should discuss the financial agreement with the investigator and agree upon who is responsible for this process at the investigational site. The monitor should prepare the financial agreement with the investigational site in accordance with local legislation and obtain a signed agreement before the study initiation visit Financial Disclosure The monitor should discuss and obtain a signed Financial Disclosure Form from all investigators and sub-investigators of the study team where applicable before the study initiation visit edc studies When the study will be performed using an electronic CRF the monitor should discuss the acceptability with the investigator and find out what IT environment, Operative system and web browser, is used at the site. This should be documented in the pre study report. 5.2 Documenting the Visit Pre-Study Report A Pre-Study Report will be written after every visit and sent to the person appointed to review the report within 10 working days of the monitoring visit. The date that the report was written should be recorded on the report Issues Any significant issues resulting from the pre-study visit should be reported in writing ( is acceptable) within 2 working days of the visit to the PL and/or Lead CRA. The PL and/or Lead CRA should take appropriate action such as contacting the sponsor. Critical issues should be reported to the PL and/or Lead CRA immediately, by phone Review The reviewer should review the report within 5 working days (the review date should be documented) and send any comments to the Monitor who will have a further 5 working days to amend the report. The reviewer will conduct a final review and the report will be signed by the monitor within 25 days from the date of the visit and sent to the reviewer for sign off.

8 Page 8 (9) When other timelines have been agreed with the sponsor this should be documented. The primary purpose of the review is for the project management to be aware of any issues at the site and to ensure that they are, when deemed necessary, adequately addressed and reported to the sponsor Filing The original of the report should be filed in the Study Master File Follow up with the Investigator The Monitor will write a follow-up letter in COSMOS including findings and agreements. The follow up letter should be sent to the investigator within 10 days of the visit. The letter should clearly identify any significant findings/facts, deviations and deficiencies, conclusions and outstanding issues. The original letter should be sent to the site and a copy sent for filing in SMF. The follow-up letter will be written in English and can be translated into local language if requested by the site Clinical Site Agreement It is the responsibility of the monitor to discuss with the Sponsor the need for a study agreement in the study if required. The monitor shall prepare a master version of the Clinical Site Agreement or use one supplied by the Sponsor. The master version shall be reviewed by the Sponsor before distribution to the study sites. In a multicentre study the draft study agreement shall be discussed with each study site. After finalisation the principal investigator and the appropriate person at TFS normally the Regional Managing Director or equivalent, shall sign and date the Clinical Site Agreement. The Clinical Site Agreement shall be signed before initiation of the study. The steps taken and decisions made shall be documented. 6. SITE SELECTION The decision to include the site should be based on the pre study site visit (if done) and previous knowledge and/or experience of the investigator/site and documentation provided by the investigator. The Sponsor should be involved in the decision as to whether to include the site or not unless they have clearly indicated that this decision should be made by TFS alone.

9 Page 9 (9) DOCUMENT HISTORY Version No Effective Date Brief Description of Change New training required 01 1 Feb 2002 New SOP (CS08) September 2006 General update to harmonise TFS and CDC SOPs April 2013 Clarification of review procedures and other minor changes December 2013 Removal of the requirement for a pre-study visit in certain cases, and revised procedure in follow up with investigator Yes No EXTENSION WITHOUT CHANGES Review date Extension valid QA Approval to 9 Sep Sep 2010 Approved directly on the SOP. 10 Sep March 2011 Approved directly on the SOP. 3 March March 2012 Approved directly on the SOP. 1 March March 2014 Approved on the extension page.