there is to be no prior writte n or electronic record of data). 8.5 Training of staff The principal inves tigator will maintain a record of all individuals involved in the trial (medical, nursing and other staff). He or she will ensure that appropriate training relevant to the trial is given to all these staff, and that they will receive any new information of relevance to the performance of this trial. 8.6 Trial agreements The principal investigator at each centre must comply with all the terms, conditions and obligations of the trial agreement for this trial. In the event of any inconsistency between this protoc ol and the trial agreement, the trial agreement shall prevail. 8.7 Confidentiality The Investigators must agree to maintain the confidentiality of the trial at all times and must not reveal information relating to the Investigator's Brochure, protocol, CRFs or associated documents to unauthorised third parties. 9. TRIAL MANAGEMENT 9.1 Monitoring Before the initiation of the trial, a representative of Targovax will visit the investigational site to: • Determine the adequacy of the facilities • Discuss with the investigator (s) (and other personnel involved with the trial) their responsibilities with regard to protocol adherence, and the responsibilities of Targovax or its representatives During the trial, a CRA representing Targovax will have regular contacts with the invest igational site, including visits to: • Provide information and support to the investigator(s) • Confirm that facilities remain acceptable • Confirm that the investigational team is adhering to the protocol, that data are being accurately recorded in the CRFs, an d that investigational product accountability checks are being performed • Perform source data verification (a comparison of the data in the CRFs with the patients’ records at the hospital or practice, and other records relevant to the trial). This will req uire direct access to all original records for each patient (e.g. clinic charts) The monitor or another Targovax representative will be available between visits if the investigator(s) or other staff at the centre need information and advice. The monitoring of the study will be conducted by a Targovax representative who has appropriate expertise in monitoring clinical trials such as this to ICH GCP standards. CT TG01 -01 Version v 10.0 27 June 2018 Confidential 79 / 87 9.2 Audits and inspections Authorised representatives of Targovax, a regulatory authority, an IEC or an IRB may visit the centre to perform audits or inspections, including source data verification. The purpose of an audit or inspection is to systematically and independently examine all trial- related activities and documents to determine whether these activities were conducted, and whether data were recorded, analysed and accurately reported according to the protocol, Good Clinical Practice (GCP), guidelines of the International Conference on Harmonisation (ICH), and any applicable regulatory requirements. The investigator should contact Targovax immediately if they are contacted by a regulatory agency about an inspection at their centre. 9.3 Case report form handling The main objective is to obtain those data required by the trial protocol in a complete, accurate, legible and timely fashion. The data in the CRFs should be consistent with the relevant source documents. The data recorded during the course of this trial must be documented in the CRFs and must be forwarded to the nominated Data Management Group, for processing and evaluation on behalf of Targovax. All data must be stored in an anonymous form in accordance with the data -protection regulations. The Investigators must ensure that the CRFs forwarded to Data Management and any other associated documents, contain no mention of any patient names. The CRFs must be filled in completely and legibly (with either black or blue ballpoint pen, acceptable for use on official documents). Any amendments and corrections necessary must be undertaken and countersigned by the Investigators, stating the date of the amendment/correction. Errors must remain legible and may not be deleted with correction aids (e.g. Tipp-Ex). The Investigators must state their reasons for the correction of important data. In the case of mi ssing data/remarks, the entry spaces provided for in the CRF should be cancelled out so as to avoid unnecessary follow-up inquiries. The CRFs must be suitable for submission to the regulatory authorities. The nominated Data Management Group is Syne Qua None Ltd . with headquarters at Gostling House, Diss Business Park, Hopper Way, Sandy Lane, Diss, Norfolk, IP22 4GT, UK and will have the appropriate experience to undertake the data management and statistical activities for this study to ICH GCP standards. 9.4 Amendments to the trial protocol Changes in the trial protocol must take the form of written trial- protocol amendments.