NEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES

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1 NEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES SOP details SOP title: SOP number: SOP category: Document Control GE-003 General SOP history Version number: 01 Version date: 1 March 2013 Effective date: 1 March 2013 Revision by date: 28 February 2015 SOP author details Author name: Author position: Author signature: Date: Chris Speed Senior Trial Manager This electronic version is uncontrolled. The signed controlled copy is held in the Newcastle Clinical Trials Unit Administration Office. SOP reviewer details Reviewer name: Reviewer position: Reviewer signature: Date: Jennifer Wilkinson Senior Trial Manager This electronic version is uncontrolled. The signed controlled copy is held in the Newcastle Clinical Trials Unit Administration Office. SOP approver details Approver name: Approver position: Approver signature: Date: Professor Elaine McColl Director, Newcastle Clinical Trials Unit This electronic version is uncontrolled. The signed controlled copy is held in the Newcastle Clinical Trials Unit Administration Office. STATEMENT This is a controlled document. The master document is posted on the NCTU website: Any print-off of this document will be classed as uncontrolled. Researchers and their teams may print off this document for training and reference purposes but are responsible for regularly checking the NCTU website for more recent versions. SOP NCTU: GE-003 Version: 01 Version date: 1 Mar 2013 Page 1 of 9

2 SOP revision record Version number Date Reason for revision 01 1 March 2013 Document release SOP NCTU: GE-003 Version: 01 Version date: 1 Mar 2013 Page 2 of 9

3 1. BACKGROUND Newcastle Clinical Trials Unit (NCTU) Standard Operating Procedures (SOPs 1 ) are designed to ensure that clinical research and its supporting activities are conducted to the principles of Good Clinical Practice (GCP) 2,3,4. GCP is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of trials that involve the participation of human subjects. Compliance with GCP provides assurance that the data and reported results are credible and accurate and that the rights, wellbeing and safety of participants are protected. Good documentation and document control is essential for ensuring the safety of participants and the quality of data in clinical trials. It must be possible to track any document used in any part of the trial to demonstrate approved, current procedures were used by trained staff. All documents must also be prepared to meet regulatory and local requirements. Controlled documents include administrative, clinical and data management documents which meet the criteria for essential documents as described in the ICH Guidelines for Good Clinical Practice 5 e.g. protocols, participant information sheets (PIS) and informed consent forms (ICF), GP letters, advertisements, and data collection media including case report forms. In addition, non-study specific documents such as policies, standard operating procedures, forms, Quality Control (QC) and Quality Assurance (QA) data and risk assessments should be controlled to an appropriate level. Different types of documents will need different levels of control. Some documents may not be formally controlled (e.g. staff CVs) however, procedures should be in place to ensure these are updated regularly and only current versions are accessible. For other documents (e.g. Participant Information Sheet) it is essential that only the current approved version is used, otherwise key information may not be communicated. For these, a higher level of control is required. The appropriate document control procedure should be applied to all documents produced by the Newcastle Clinical Trials Unit (NCTU). For documents generated externally (e.g. guidelines or organisational policies, commercially-sponsored study protocols) it is important to ensure that current versions are available, although it may not be necessary to incorporate all external documents into a control process. The key elements of controlling documents are described below, and include: standardised formats to improve consistency of use author and approval processes version control and numbering training, issue and distribution review access, security, storage and archiving master list of documents responsibilities Systems used to control documents will vary according to the needs of the Unit. They will range from simple, paper based systems to databases or more complex commercially provided software solutions. The range of documents that must be controlled is extensive and several systems are likely to be employed. SOP NCTU: GE-003 Version: 01 Version date: 1 Mar 2013 Page 3 of 9

4 2. PURPOSE This SOP describes the range of controlled documents that may be produced or used by NCTU and how such documents may be managed to ensure they are fit for purpose and are accessible when needed. 3. SCOPE This SOP system applies to all personnel carrying out clinical research, or related, activities within trials managed and/or monitored by the NCTU. 4. RESPONSIBLE PERSONNEL Chief Investigator (CI) / Principal Investigator (PI): Must ensure that all controlled documents required for the clinical research study are accessible and fit for purpose, and are appropriately managed and controlled. Document Controller: Must ensure that all controlled documents related to clinical research are: Approved and follow the guidelines for version control and naming of documents and are in the correct format. Implemented within the NCTU and that staff are appropriately trained in the use of the documents. Training will usually be performed by the author or other suitably qualified staff. Reviewed at regular intervals and remain fit for purpose. Accessible to all users when required and are being followed. All staff: Must ensure they are trained to perform the process outlined in a document, and that this training is documented. Staff should not deviate from a procedure. If staff become aware that a document is out of date or inaccurate, they must report this to the author/owner or Document Controller. 5. DEFINITIONS 5.1 Acronyms and abbreviations SOP Standard Operating Procedure QA/QC Quality Assurance/Quality Control GP General Practice/Practitioner 5.2 Definitions Controlled documents Document controller Written or electronic information or templates that are used to convey or record information, and that are approved, reviewed and made available to staff. A document must be controlled if an unapproved change may result in a process being performed incorrectly. For the purposes of this SOP, the term document refers to a controlled document, unless stated specifically. An individual who has the responsibility of ensuring controlled documents are managed according to this Document Control SOP. This may be a Quality Assurance (QA) manager or similar for non-study-related documents and/or a senior member of the study team for study-specific essential documents. SOP NCTU: GE-003 Version: 01 Version date: 1 Mar 2013 Page 4 of 9

5 Essential documents Policy Procedure Form User Review Approval Issue Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced. A statement that communicates the intent, objectives, requirements, responsibilities, and standards for an organisation. A particular method for performing a task. A document that defines the range of data to be collected and allows entry of that data. Any individual who uses and applies the information in a controlled document to perform a particular procedure. A checking process, performed by an expert (the reviewer) in the procedure that ensures the document is fit for purpose. A process whereby a document is certified as ready to be used. A process whereby an approved document is made available to users. 6. PROCEDURE 6.1 Types of document Document Type Location Responsibility (Department) Policies NCTU Director s Office NCTU Administration Team Study documents SOPs Trial Master File (held in NCTU) & Site files (at site) NCTU Website (uncontrolled) Controlled copy held in NCTU Administration Office Study team NCTU Management Group Review Period Annual Dependent on study activity but related documents should be reviewed together Biennially Forms As SOPs As SOPs Biennially Records/Results Study files Study team Prior to release to Sponsor or annually for staff records Databases Hosted on secure third party Server (Infermed MACRO) & Local secure network servers Database manager/it support Reference documents NCTU Director s Office NCTU Management Group At each software update Document controller should receive update information in real time SOP NCTU: GE-003 Version: 01 Version date: 1 Mar 2013 Page 5 of 9

6 Equipment manuals With equipment Equipment owner Routine service period 6.2 Externally produced documents Many documents used in clinical research are likely to have been produced by external authors/ organisations e.g. guidelines (e.g. ICH GCP), equipment manuals and Trust or University policies. It is important that current versions of such documents are accessible and that they are subject to similar control processes as other documents so that updated versions are obtained and staff are aware of updated information. Such documents may have a different numbering system depending on their origin. It may be appropriate to simply record a list of the types of external documents and their locations (e.g. User manuals stored with equipment). Alternatively, such documents may be given an internal NCTU number which complies with the unit s document control procedure. 6.3 Version control and numbering All documents must comply with a standard numbering system to ensure that only current versions are used. The version number and title must be consistent throughout the document. The version numbering system for the NCTU name is set out below SOPs Please see SOP NCTU:GE-001 for details of SOP version control Protocols, Information Sheets and other documents in need of version control Draft versions should be numbered 0.x, where the leading zero is the draft status identifier and the second digit(s) is the version number. Where possible (either by electronic watermark or annotation on the documents) the word DRAFT should appear. The date of the revision must also be included. The first approved version of a document (i.e. no longer draft) should be given the identifier Version 1.0 and the approval date. If a minor amendment is made the second digit is updated to reflect this (Version 1.0 will become Version 1.1 following a minor amendment). The date will be revised to reflect this change. When a substantial amendment is made the version number will be changed from Version 1.0 to version 2.0. The date will be revised to reflect this change. Obsolete versions of documents must be marked thus Superseded by (new version and date). All documents for internal use may be annotated with identification of their status (e.g. Draft, Effective/Controlled copy, Not in use/obsolete). For electronic copies this can be done using the watermark facility. Hard copies should be marked on each page. 6.4 Naming of electronic documents When saving documents as electronic files, the filename should accurately reflect the document title, using abbreviations and acronyms only if clear. The filename should provide sufficient information to identify the document including the version (this may be by adding the version number and/or date to the filename). SOP NCTU: GE-003 Version: 01 Version date: 1 Mar 2013 Page 6 of 9

7 6.5 Essential information All documents should have the following information available either on the front page or as a header/footer on each page: Institution/Unit name Title, document number or code and version number these should ensure that every document is uniquely identifiable. Additionally, names of individuals responsible for document (author/owner/approver), Page number and the effective date may be added to documents if appropriate. 6.6 Author and approval process Documents should always be written by qualified personnel with expertise in the area of the document. Templates should be used for writing SOPs and study protocols. If templates are not available, SOPs should document required content. Draft documents should be circulated for peer and quality review before the document can be approved. The approver should be a line manager or higher, with the experience and knowledge of the process to enable them to permit the document s use. SOPs and Policy Documents must be signed off by the NCTU Director and/or the Deputy Director. 6.7 Training, issue and distribution The NCTU Management Group will be responsible for deciding the training issues arising from the adoption of a new or revised document. Before a new or revised document can be used, all users must be made aware of and, if necessary, be trained in, the new version. All relevant staff must be able to demonstrate that they are competent to use the procedure outlined in the document. Document training methods and how these events are recorded are outlined in separate training procedures, but will range from simple notification (e.g. reviewed, but unchanged SOPs, forms) through a requirement to read only (policies etc.) to competency testing (SOPs, consent etc.). The relevant document controller will ensure that each document is made available for training following approval and prior to issue. Once existing staff have been trained, the document will become effective (a specific date should be identified from which point the new procedure replaces the old). At this time, all existing copies (if applicable) should be replaced with the new version. 6.8 Review process All controlled documents are reviewed prior to first issue, when initial drafts are circulated. Major changes in content should be recorded (in the document if possible). All non-study specific controlled documents are also subject to periodic review. This process is managed by the document controller who maintains a list of documents and their review periods. When a document is due for review, the document controller releases a new editable draft copy to the reviewer, who updates the text as required and returns the document to the document controller to manage the approval and issue process. SOP NCTU: GE-003 Version: 01 Version date: 1 Mar 2013 Page 7 of 9

8 6.9 Access, security, storage and archiving Access Only current versions of documents should be available to document users. These individuals may be designated as having read-only access. The current version must NOT be available to users in an editable format (pdf. copies are commonly used). At NCTU, documents are accessed from the following locations, and as listed in section 7.1: Trial documentation Trial Master File (NCTU offices) and Electronic Trial Master File (NCTU secure network). Institute of Health and Society and NCTU policy Documents via the password protected Sharepoint service and/or NCTU secure password protected shared folders on the network Security and storage Paper copies of documents are stored in locked cabinets in locked offices within NCTU. Electronic versions of documents are stored on password protected drives on the University of Newcastle network. Where appropriate security measures should include: Protection from editing (e.g. pdf. copies, read only word copies) Back up of electronic copies Password protection at network, folder or document level Facilities for storage of paper copies (e.g. archiving environment to protect from moisture/fire) Mobile storage policy Security of databases Archiving and retention Previous versions should be marked as superseded and be securely archived. They must not be accessible to users except to trial management and the document controller. With regard to trial specific documentation/paperwork, one hard copy of all final versions of a document should be retained until after the completion of the study. The retention time and archiving method will be included in the study protocol and departmental archiving procedures. Retaining superseded and obsolete documents as electronic copies only (i.e. not retaining a hard copy) should only be performed if a fully validated process has been established to ensure that the electronic version accurately reflects the hard copy and that there is no increased risk of loss of access or ability to view the document by not retaining a hard copy. 7. REVIEW AND MONITORING OF THIS DOCUMENT In accordance with NCTU policy NCTU: GE-001. SOP NCTU: GE-003 Version: 01 Version date: 1 Mar 2013 Page 8 of 9

9 8. REFERENCES (hyperlinks verified on date published) 1. SOP NCTU:GE-001 Standard Operating Procedure System 2. Medicines for Human Use (Clinical Trials) Regulations 2004, Schedule 1, Part 2 at: 3. The Medicines for Human Use (Clinical Trials) Amendment (No.1) Regulations SI (2006/1928) at: 4. The Medicines for Human Use (Clinical Trials) Amendment (No.2) Regulations SI (2006/2984) at: 5. CPMP/ICH/135/95: Guideline for Good Clinical Practice ICH E6 (R1) at: SOP NCTU: GE-003 Version: 01 Version date: 1 Mar 2013 Page 9 of 9

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