NEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES

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1 SOP details SOP title: SOP number: SOP category: Version number: 03 Version date: 19 December 2016 Effective date: 19 January 2017 Revision due date: 19 January 2020 NEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES Application and Maintenance of a Clinical Trial Authorisation from the Competent Authority TM 002 Trial Management SOP author details Author name: Author position: Author signature: Date: Amy Cranston Trial Manager This electronic version is uncontrolled. The signed controlled copy is held in the Newcastle Clinical Trials Unit. SOP authoriser details Authoriser name: Authoriser position: Authoriser signature: Date: Jill Peacock Quality Assurance Manager This electronic version is uncontrolled. The signed controlled copy is held in the Newcastle Clinical Trials Unit. STATEMENT This is a controlled document. The master document is held within NCTU with a controlled copy posted on the NCTU website: Any print off of this document will be classed as uncontrolled and should not be filed. The reader is responsible for regularly checking the NCTU website for more recent versions. SOP NCTU: TM 002 Version: 03 Version date: 19 DEC 2016 Page 1 of 8

2 SOP revision record Version number Date Reason for revision March 2013 Document release January 2014 Document revision December 2016 Move across to new template, update to processes and addition of CSP Table of Contents 1. BACKGROUND PURPOSE SCOPE ROLES & RESPONSIBILITES ACRONYMS PROCEDURE Requirement for a CTA CTIMP Definition Type A clinical trials Responsibility for submitting the request for CTA EudraCT Obtaining a EudraCT number How to complete and submit a CTA application VHP Correspondence with MHRA Labelling of IMPs Maintaining a CTA Safety reports Declaration of the end of the trial Final Trial Report REVIEW AND MONITORING OF THIS DOCUMENT ASSOCIATED DOCUMENTS... 8 SOP NCTU: TM 002 Version: 03 Version date: 19 DEC 2016 Page 2 of 8

3 1. BACKGROUND Under current legislation, a Clinical Trial of an Investigational Medicinal Product (CTIMP) must not commence in the United Kingdom (UK) until an application for authorisation has been made to the Competent Authority, and the Competent Authority has not stated any reasons for nonacceptance and has authorised the application. In the European Economic Area (EEA), each Member State (MS) has an appointed Competent Authority (CA) which performs functions required by European Clinical Trials Directive (2001/20/EC). The Medicines and Healthcare Products Regulatory Agency (MHRA) is the UKs licensing authority established under the Medicines Act 1968 and the Competent Authority in the UK. All Clinical Trial Authorisation (CTA) submissions and subsequent amendments to a CTIMP must be made to the MHRA for review and approval. 2. PURPOSE The purpose of this Standard Operating Procedure (SOP) is to: Confirm when CTA is required. Describe how to request CTA from the MHRA. Describe how to maintain CTA, including amendments following authorisation by the MHRA and notification of the end of a trial. For trials taking place in more than one MS, a separate application is required to the Competent Authority of each member state involved. Guidance should be sought from the relevant Competent or Regulatory Authority in each case. If the submission is part of a Voluntary Harmonisation Procedure (VHP) see section for guidance. 3. SCOPE This SOP applies to all Trial Managers involved in the set up and management of a CTIMP managed and/or monitored by the Newcastle Clinical Trials Unit (NCTU). This SOP also applies to Assistant Trial Managers and Clinical Trial Administrators involved in assisting Trial Managers with the set up and amendment processes for a CTIMP. This SOP is applicable to all CTIMPs involving human participants where NCTU has been delegated the duty of obtaining the CTA. It should be followed by all staff when setting up a clinical trial that falls within the scope of the European Clinical Trials Directive 2001/20/EC. 4. ROLES & RESPONSIBILITES The Chief Investigator (CI) is responsible for submitting and maintaining a CTA even when these duties have been delegated to the Trial Manager. The Trial Manager, or delegate, is responsible for preparing and submitting the CTA application and subsequent amendments with input from the Trial Management Group (TMG). SOP NCTU: TM 002 Version: 03 Version date: 19 DEC 2016 Page 3 of 8

4 5. ACRONYMS CESP CI CA CTA CTIMP DSUR EC EEA EU EudraCT IMP IRAS MS MHRA NCTU PDF REC SOP TMF TMG UK VHP Common European Submission Platform Chief Investigator Competent Authority Clinical Trial Authorisation Clinical of an Investigational Medicinal Product Development Safety Update Report European Commission European Economic Area European Union European Union Drug Regulating Authorities Clinical Trials Investigational Medicinal Product Integrated Research Application System Member State Medicines and Healthcare products Regulatory Agency Newcastle Clinical Trials Unit Portable Document Format Research Ethics Committee Standard Operating Procedure Trial Master File Trial Management Group United Kingdom Voluntary Harmonisation Procedure 6. PROCEDURE 6.1 Requirement for a CTA The requirement to obtain CTA applies only to CTIMPs (definition below) that fall within the scope of the European Clinical Trials Directive 2001/20/EC. A CTA is not required for studies involving only food supplements, other non medicinal therapies (such as surgical interventions) or non interventional trials. For studies involving only medical devices, a Notice of No Objection may need be to be obtained and further information should be sought from the MHRA website CTIMP Definition A clinical trial that is within the scope of the UK Medicines for Human Use (Clinical Trials) Regulations An investigation in human subjects, other than a non interventional trial, intended: a) To discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more medicinal products, b) To identify any adverse reactions, or c) To study absorption, distribution, metabolism and excretion, with the object of ascertaining the safety and/or efficacy of those products. SOP NCTU: TM 002 Version: 03 Version date: 19 DEC 2016 Page 4 of 8

5 Further guidance on the definition of a CTIMP is provided by the European Commission (EC) in the Volume 10 algorithm. If, after using the algorithm, it is still unclear whether or not a clinical study falls under the scope of the regulations, clarification should be sought from the MHRA (contact details for the MHRA can be found on their website). 6.2 Type A clinical trials Type A trials conducted in the UK will only require to be notified to the MHRA. Further information on the definition of a Type A trial and procedure for application is available on the MHRA website. Type A Trials: Trials where the risk is no higher than the risk of standard medical care. Trials involving medicinal products licensed in any European Union (EU) MS if: They relate to the licensed range of indications, dosage and form; or They involve off label use (such as in paediatrics and in oncology etc.) if this off label use is established practice and supported by sufficient published evidence and/or guidelines. 6.3 Responsibility for submitting the request for CTA The submission should be prepared and submitted by the Trial Manager in collaboration with the CI. Additional stakeholders may be involved in the submission (e.g. sponsor contact, pharmacy or medicines management and the clinical trials supply company etc.). Applications may be made either by: The Sponsor, or Someone authorised to submit the request on behalf of the Sponsor written confirmation must be provided to authorise the person submitting the request to act on behalf of the Sponsor If the Sponsor is not established in the EEA, i.e. in a EU country, or Norway, Iceland or Liechtenstein, there must be a legal representative who is so established (e.g. an individual person or a representative of a corporate entity). The Trial Manager should allow adequate time for Sponsor and CI review and authorisation in Integrated Research Applications System (IRAS) before submission. Concurrent submission of CTA and ethics application should also be considered. 6.4 EudraCT The European Union Drug Regulating Authorities Clinical Trials (EudraCT) database provides a register of all clinical trials within the EC under the scope of the European Clinical Trials Directive 2001/20/EC5. A clinical trial must be registered on the EudraCT database prior to submission to the Competent Authority (ies). The Trial Manager or delegate must register a trial on the EudraCT database and to obtain the EudraCT number Obtaining a EudraCT number SOP NCTU: TM 002 Version: 03 Version date: 19 DEC 2016 Page 5 of 8

6 The Trial Manager or delegate should follow the procedures for obtaining a EudraCT number as outlined on the EudraCT website. The EudraCT number will be received in an and a copy of this should be filed within the Trial Master File (TMF). The unique EudraCT number should be quoted in all communication (including the original CTA submission, amendments, safety reports and end of trial report). 6.5 How to complete and submit a CTA application The CTA application form is accessed and completed online via the IRAS and further information is available within the NCTU CTA Working Instruction. A submission fee is also payable and prior to submission to the MHRA, the CI (or Trial Manager) must authorise and arrange payment of the required fee to the MHRA. The EudraCT number should be used as a payment reference. Proof of payment of the fee must be sent with the application package to ensure the validity of the application. Documents, as listed in the checklist on IRAS, should be submitted as Portable Document Format (PDF) versions. Guidance is provided on the MHRA website, and covers what to send and preparation of PDF documents. The Common European Submission Platform (CESP) should be used to submit documents to the MHRA for review. Further information no making a submission through CESP is available in the NCTU CESP User Guide VHP If the CTA submission is part of a multinational clinical trial application it may go through the VHP. VHP is the assessment process used for multinational clinical trial applications with the aim of harmonising the conduct of clinical trials within EU member states. This process occurs prior to the national process and is voluntary. The Sponsor of the clinical trial is responsible for the VHP submission via a VHP coordinator. The national competent authorities participating in the VHP assessment will review the submission through this process. If the VHP approval is granted, there is a 20 day deadline for all national level submissions. The Trial Manager must complete the CTA in IRAS and ensure all documents submitted via VHP are included in the submission. The fee must also be paid at this point and once the submission is made, the MHRA will have 10 days to send the national approval through Correspondence with MHRA Once an application has been made, the MHRA will correspond directly with the contact as listed in section C1 of the IRAS CTA form. However, the sponsor can give a SOP NCTU: TM 002 Version: 03 Version date: 19 DEC 2016 Page 6 of 8

7 password to be used by other persons who may contact the MHRA (e.g. the Trial Manager) and this password must be listed on the covering letter to accompany the CTA application. The Trial Manager should request a password from the sponsor in order to ease communications with the MHRA should a problem arise. In the event of a non acceptance of a CTA application, the MHRA will write to the Sponsor (or person named in C1) and may include a limited time for response to the non acceptance in their letter. This also applies to substantial amendments. The Trial Manager must ensure that a copy of all correspondence is filed within the Trial Master File Labelling of IMPs An example of the Investigational Medicinal Product (IMP) label must be submitted with the CTA application. Labelling requirements in the UK must be in accordance with guidance provided by the European Commission Annex 13 and the Medical Research Council/Department of Health (MRC/DH) Joint Project. The Trial Manager must ensure that the Sponsor and any other applicable parties have reviewed and agreed the proposed label prior to submission. 6.6 Maintaining a CTA Non substantial amendments may be made at any time without approval from the MHRA however the Trial Manager must ensure that these amendments are submitted to the Health Research Authority for approval. Details of the non substantial amendments should be included for information with the next substantial amendment request submission to MHRA. If the Sponsor wishes to make a substantial amendment, appropriate amendment documents must first be submitted and authorised by the Competent Authority (and Research Ethics Committee (REC), where relevant). Urgent amendments may be implemented without prior authorisation from the Competent Authority or REC where urgent safety measures are required to protect subjects. Further information is available in NCTU SOP TM 014 Urgent Safety Measures. A notification of substantial amendment form should be completed in IRAS, with the initial CTA application form highlighted to show changes (if applicable). The Trial Manager should submit these to MHRA along with any amended documents together and the proof of payment of the substantial amendment fee. The CI and sponsor are required to authorise the substantial amendment via IRAS before submission via CESP to MHRA using the same method as the initial application. The Trial Manager should ensure that adequate time is given to allow for this. For those CTIMPs that pre date IRAS/CESP, substantial amendments may still require submission on disc and sent directly to the MHRA Safety reports The Development Safety Update Report (DSUR) is the safety report submitted to the MHRA on an annual basis. Further information on DSURs can be found in NCTU SOP TM 003 Safety Reporting in CTIMPs and ATMPs as well as the NCTU Development Safety Update Report Working Instruction. SOP NCTU: TM 002 Version: 03 Version date: 19 DEC 2016 Page 7 of 8

8 6.7 Declaration of the end of the trial The definition of the end of the trial should be documented in the study protocol and original CTA application. Any change to this definition should be notified as a substantial amendment. The CA should be notified of the end of the trial in their country and when the trial is completed in all countries involved (both inside and outside the EC) within 90 days of the end of the trial. If the trial terminates early the signed End of Trial form will be submitted within 15 days of the end of trial to the MHRA and REC. 6.8 Final Trial Report Within 12 months from the End of Trial Declaration, the Final Trial Report is required to be submitted to the MHRA. Further information is available in NCTU SOP TM 009 Clinical Study Report. 7. REVIEW AND MONITORING OF THIS DOCUMENT This SOP will be reviewed every three years unless there is a change to the applicable legislation or significant revision to the process contained in the SOP. Compliance with this SOP will be monitored through Senior Trial Manager oversight at regular scheduled 1:1 meetings with Trial Managers. In addition compliance with the requirements of this SOP will be assessed through the annual internal audit schedule. 8. ASSOCIATED DOCUMENTS NCTU SOP GE 001 Standard Operating Procedures NCTU SOP TM 003 Safety Reporting in CTIMPs and ATMPs NCTU SOP TM 009 Clinical Study Report NCTU SOP TM 014 Urgent Safety Measures NCTU Clinical Trial Authorisations Working Instruction NCTU Development Safety Update Report Working Instruction NCTU CESP User Guide SOP NCTU: TM 002 Version: 03 Version date: 19 DEC 2016 Page 8 of 8

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