STANDARD OPERATING PROCEDURE FOR RESEARCH. Management of Essential Documents and Trial Folders

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1 STANDARD OPERATING PROCEDURE FOR RESEARCH Management of Essential Documents and Trial Folders Author Linda Ward Author s Job Title QA Coordinator Division Department Version number 2 Ref SOP/CLN/001/2 Manager responsible for review Professor Adrian Harris Location of previous SOP Medical Oncology and the Oxford Experimental Cancer Medicine Centre Whereas every care has been taken in the preparation of these publications, the author/s and the author s institution, Cancer Research UK and the devolved departments of health for England, Northern Ireland, Scotland, Wales or any supporting organisation cannot be responsible for the accuracy of any statement or representation made or the consequences arising from the use of or alteration to any information contained in it. These procedures are intended solely as a general resource for practising professionals in the field, operating in the UK, and specialist advice should be obtained where necessary. 1

2 INDE 1. INTRODUCTION SCOPE RESPONSIBILITIES REFERENCE AND RELATED DOCUMENTS DEFINITIONS GENERAL PRINCIPLES OF ESSENTIAL DOCUMENT MANAGEMENT SECURITY AND ACCESS ASSIGNMENT OF RESPONSIBILITY FOR DOCUMENT CONTROL EARLY DEVELOPMENT PHASE TRIAL SET-UP PRIOR TO SITE ACTIVATION AND CLINICAL RECRUITMENT DOCUMENT MAINTENANCE DURING THE COURSE OF THE TRIAL MANAGEMENT OF ELECTRONIC VERSIONS OF DOCUMENTS ON COMPUTER ESSENTIAL DOCUMENT DISTRIBUTION AND CIRCULATION TRIAL CLOSURE AND ARCHIVING IMPLEMENTATION... 6 APPENDI 1 ICH GCP GUIDELINES FOR TRIAL DOCUMENTATION INTRODUCTION 1.1. Well-organised trial files and good document control are essential to efficient, GCP compliant trial management. They also facilitate monitoring, audit and inspection ICH Good Clinical Practice (GCP) guideline (E6 section 8, Appendix 2) defines Essential Documents as those documents which individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. The guideline lists specific essential documents in 3 phases: 1) to be present in file before the clinical phase commences; 2) to be generated during the clinical conduct phase; and 3) produced and retained after the trial has ended. These documents must be recorded, handled and stored in such a way that the trial can be accurately reported, interpreted and verified while protecting the confidentiality of records of trial subjects GCP requires both Sponsor and Investigators to maintain the essential documentation within their respective trial master file (TMF) and Investigator Site File (ISF). Sponsors of in-house trials may delegate responsibility for production and maintenance of the TMF essential documentation to the Investigator. Investigators must also provide copies of relevant documentation to other organisations that may be involved in conducting or overseeing the trial Proper trial file maintenance is a UK legal requirement for clinical trials of an investigational medicinal product (CTIMPs). The NHS Research Governance Framework extends these principles to all research projects and clinical investigations conducted in the NHS that may impact on the safety and well being of participants. When conducting non-interventional trials (non-ctimps), certain documents may not be relevant or obligatory. Researchers should interpret and apply best practice in the context of individual projects. 2. SCOPE 2.1. This SOP describes the management of essential documentation from planning stages to closure. The main body of the SOP details general procedures for document and ISF management. Archiving is the subject of separate SOPs. 2

3 3. RESPONSIBILITIES 3.1. Principal or Chief Investigators (PIs or CIs) must: Approve and sign off the essential documents. Ensure the Essential Documents relating to the trial are held in the trial file(s). Take security measures to prevent accidental or premature destruction as per ICH-GCP Allow authorised monitors, auditors, REC and regulatory authorities direct access to trial records. Retain documents long term as specified by the sponsor, applicable regulations and policies. Related duties include: Checking the documents regularly and discussing the contents of the trial files with the monitor. Document control, submission and distribution. Maintaining and completing the various logs held within the file Many of these responsibilities may be delegated to appropriate members of the study team. 4. REFERENCE AND RELATED DOCUMENTS 4.1. ICH Topic E6 Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95), Step 5, amended September Section 8: Essential documents for the conduct of a clinical trial 4.2. EU Commission Directive 2005/28/EC1 of 8 April 2005 (The GCP Directive) 4.3. UK The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 SI 2006/ EUDRALE Vol. 10 chapter V: Recommendation on the content of the trial master file and archiving (July 2006) 4.5. EU Commission: Consultation on Draft guidance on specific modalities for non-commercial clinical trials referred to in Commission Directive 2005/28/EC laying down the principles and detailed guidelines for good clinical practice [June 2006] [Section 4.4: Documentation] 4.6. SOP: Archiving Clinical Trial Documentation Work Instruction: Managing trial files during the clinical phase 4.8. Work Instruction Labelling Trial Files Current templates [others may be added as necessary]: Essential Document Tracker Log Monitoring / Audit Log Note To File Trial Delegation Log Patient Screening Log Patient Enrolment Log SAE Log Expedited Safety Report Tracker Log TMF/ISF Master Index Template 5. DEFINITIONS Acronym CI CTIMP ISF PI TMF Full name Chief Investigator (of in-house trial) Clinical trial of an investigational medicinal product Investigator Site File Principal Investigator Trial Master File 3

4 6. GENERAL PRINCIPLES OF ESSENTIAL DOCUMENT MANAGEMENT 6.1. Essential Documents are controlled documents. Staff shall routinely give the proper document title, date and version number (where available) as reference (e.g. in correspondence or enclosure lists) Document receipt, issue and withdrawal should be recorded via document control logs Trial documents must be complete, legible, accurate and unambiguous. Staff shall review both incoming and out-going material and take appropriate action to report and resolve any discrepancies The paper version of the document (original wet signed document where available) shall be the master copy for filing and retention purposes. Electronic versions of documents and key trial communications (e.g. , fax) shall be printed out and filed in the trial folder Adherence to the following working practices will help ensure that authorisations, annotations or alterations to trial essential documents are traceable as required under our quality policy. Trial documents shall be signed and dated as appropriate by the Investigator or designee. File documents will be annotated to confirm the completion of any processing instructions. Staff making entries to the documentation must be authorised to do so via the trial delegation log. Staff will write legibly in black, indelible ink and will sign and date all entries. Any changes must be made using a single strikethrough so that the original remains visible. The use of eraser fluid is not permitted. Give a reason for the change 1 where necessary Trial documents must be processed and filed without delay, to minimise the risk of loss. It is good practice to file the original and use a copy for processing, reference and distribution purposes. Documents must be filed in the appropriate section (see index or filing instructions) or else placed in the front of the folder or designated pending filing section 2. Obtain guidance i.e. from the monitor or Investigator if necessary to confirm the most appropriate filing location. Keep a single (original) file copy of each document, using appropriate tracers to cross-reference. File in reverse chronological order (most recent on top). File correspondence, notes to file etc in the section to which they refer. Use the general correspondence section sparingly and organise under sub-headings. If documentation is to be held elsewhere while the trial is running 3 (e.g. Investigator s Brochure, central record store or other folder etc) a file note or other tracer to the location of the document must be completed and placed in the relevant ISF section(s) If an essential document is missing, staff shall make every effort to trace the original or acquire a copy. If that fails, an explanatory file note is required. 7. SECURITY AND ACCESS 7.1. The trial file shall at all times contain the essential documents relating to that clinical trial All trial files must be held in a secure location and may not be removed from the premises Trial files shall be made available for licensing authority inspection at all reasonable times. They shall be made available for audit or monitoring by sponsors representatives at mutually convenient times. 8. ASSIGNMENT OF RESPONSIBILITY FOR DOCUMENT CONTROL 8.1. The PI will assign responsibility for management of the trial documentation as the trial enters the formal regulatory application and set-up phase. This will usually be managed via the delegation log. 9. EARLY DEVELOPMENT PHASE 9.1. Documents relating to protocol development or feasibility testing or initial negotiations must be held securely by the PI or their deputy (e.g. their Personal Assistant), who will: 1 Notes to file are acceptable; a changed document may append /cross-reference supporting material. 2 Documents shall be placed in the front of the relevant folder in reverse date order until ready to file 3 Acceptable only if the material is retained securely as per GCP and is easily assessable on demand. 4

5 Assign a unique (temporary) identifier to the trial for internal reference and filing purposes Create a temporary trial file for each trial and ensure that all documents relating to the trial are filed together Retain draft protocol versions, review comments, minutes, correspondence, and the like Ensure that their filing system enables easy identification, accurate filing and retrieval of documents relating to multiple trials Should a trial not proceed, staff will follow the PIs instructions (referring to any confidentiality agreement that is in place) for the disposal or return of trial documentation. 10. TRIAL SET-UP PRIOR TO SITE ACTIVATION AND CLINICAL RECRUITMENT During this phase, the documentation required before patient recruitment can commence will be generated [Appendix 1, part 1 refers] and physical trial folders are produced to contain them External sponsors should provide filing instructions and indexed files with section dividers, to hold the trial documents. If not, staff will produce these in-house The study team will liaise with the sponsor, monitor, co-investigators and others as necessary to agree the list of documentation required before clinical recruitment can commence at the site Relevant documents generated in planning phase will be collated and filed in the trial folder Staff shall produce any in-house documentation that is required and will provide copies for the sponsor trial master file on request. Documentation to be generated typically includes: Site contact information Completed Site Delegation Log Signed/dated Curriculum Vitae(s) of Investigator and relevant research staff Normal Ranges, Accreditation Certification or QC documents and representative CV (if applicable) of local diagnostic laboratories. Others as applicable to the trial The study team will take appropriate action to apply for and obtain the required trial approvals in a timely fashion (as agreed between sponsor and investigator). 11. DOCUMENT MAINTENANCE DURING THE COURSE OF THE TRIAL Staff shall refer to the Work Instruction titled: Managing trial files during the clinical phase CLN/001A Additional essential documents will be generated and added to the file during the course of the trial as per the trial protocol, filing plan and any specific CI or sponsor / monitor requirements. The GCP checklist [Append#] refers. Additional folders may be added freely to manage the increasing volume of documents. The folder index shall be updated as necessary to reflect current organisation A master copy of any previously approved document version that becomes obsolete or is withdrawn during the course of the trial shall be retained in a section of the folder designated for that purpose The trial folders shall be reviewed periodically by the responsible staff and by the monitor The SOP Archiving Clinical Trial Documentation [CLN/017] refers. 5

6 12. MANAGEMENT OF ELECTRONIC VERSIONS OF DOCUMENTS ON COMPUTER In addition to the paper master copy of an essential document, an e-version (where available) will be retained on the central server for ease of reference and use by the study team Staff will create a new Trial Folder in the active trials folder on the trials volume of the central file server. The folder will be assigned a short, recognisable name PLUS the unique trial identifiers [e.g. REC number and ORH/PID/number. Subfolder names should be descriptive and clear Essential Documents pertaining to the trial shall be saved to the trial folder Rigorous version control shall be applied to documents intended for clinical use [i.e. Protocol, Patient Information Sheet, Consent Form, GP letter, SAE forms, clinic checklists etc]. Any document that has not yet been fully approved or has been withdrawn must be clearly identified as such. In general, once approved, the current versions will be placed in a current versions sub-folder and withdrawn or obsolete versions removed to a withdrawn or obsolete version sub-folder. 13. ESSENTIAL DOCUMENT DISTRIBUTION AND CIRCULATION Investigators and their study team are responsible for ensuring that copies of essential documents are distributed as needed. The following procedures describe good practice and shall be adapted to meet trial specific needs. Maintain a trial circulation /contacts list for members of the study team. Maintain a distribution list of authorised trial document holders [i.e. those whom the investigator will supply with essential documents during the trial]. NB - These lists may be combined. Liaise with the trial document holders to ensure that the documentation relating to the research is kept up to date and synchronized across the research group and oversight bodies. Keep a record of document distribution either alongside the document(s) in the trial file or by the use of document control/ distribution logs. Document recipients will be asked to confirm receipt and to file a paper master copy of the document. Return is acceptable confirmation of receipt. Documents should be distributed electronically as.pdf files where possible. Inform copy holders as documents become obsolete or need to be withdrawn and replaced. 14. TRIAL CLOSURE AND ARCHIVING ICH GCP guidance [SOP appendix 2 part 3] cites essential documents that are to be produced and placed on file before site closure and/or closure of the trial Staff intending to archive or destroy documents held in a trial file must comply with the SOP Archiving Clinical Trial Documentation. 15. IMPLEMENTATION Existing staff who manage trial files and/or process trial documents must read this SOP and sign the appended log within eight weeks months of the issue date New staff must read and sign this SOP and have a trainer countersign the SOP log before working independently in the management of trial essential documentation, The general principles given in this SOP will apply to the management of ongoing, active trials. Established ISF/ TMFs for in-house trials need not be amended or restructured retrospectively, providing their management and content is GCP compliant Trials commencing after the SOP effective date must comply with this SOP. 6

7 Medical Oncology and the Oxford Experimental Cancer Medicine Centre APPENDI 1 ICH GCP GUIDELINES FOR TRIAL DOCUMENTATION PART 1: Before the Clinical Phase of the Trial Commences [GCP Section 8.2] During this planning stage the following documents should be generated and should be on file before the trial formally starts Located in Files of Title of Document Purpose Investigator Sponsor / Institution INVESTIGATOR S BROCHURE To document that relevant and current scientific information about the investigational product has been provided to the investigator SIGNED PROTOCOL AND AMENDMENTS, IF ANY, To document investigator and sponsor agreement to the protocol/ amendment(s) and AND SAMPLE CASE REPORT FORM (CRF) CRF INFORMATION GIVEN TO TRIAL SUBJECT- To document the informed consent INFORMED CONSENT FORM (including translations) -ANY OTHER WRITTEN INFORMATION To document that subjects will be given appropriate written information (content and wording) to support their ability to give fully informed consent - ADVERTISEMENT FOR SUBJECT RECRUITMENT (if used) To document that recruitment measures are appropriate and not coercive FINANCIAL ASPECTS OF THE TRIAL To document the financial agreement between the investigator/ institution and the sponsor for the trial INSURANCE STATEMENT (where required) To document that compensation to subject(s) for trial-related injury will be available SIGNED AGREEMENT BETWEEN INVOLVED To document agreements PARTIES, e.g. - investigator/ institution and sponsor - investigator/ institution and CRO (where required) - sponsor and CRO - investigator/ institution and authority(ies) (where required) DATED, DOCUMENTED APPROVAL/ FAVOURABLE To document that the trial has been subject to IRB/ IEC review and given OPINION OF INSTITUTIONAL REVIEW BOARD (IRB) / approval/ favourable opinion. To identify the version number and date of the INDEPENDENT ETHICS COMMITTEE (IEC) OF THE document(s) FOLLOWING: - protocol and any amendments - CRF (if applicable) - informed consent form(s) - any other written information to be provided to the subject(s) - advertisement for subject recruitment (if used) - subject compensation (if any) - any other documents given approval/ favourable opinion INSTITUTIONAL REVIEW BOARD/ INDEPENDENT ETHICS COMMITTEE COMPOSITION To document that the IRB/ IEC is constituted in agreement with GCP (where required REGULATORY AUTHORITY(IES) AUTHORISATION/ APPROVAL/ NOTIFICATION OF PROTOCOL (where To document appropriate authorisation/ approval/ notification by the regulatory authority(ies) has been obtained prior to initiation of (where the Management of Essential Documents and Trial Folders Page 7 of 12 CLN/001/2 (where (where

8 Located in Files of Title of Document Purpose Investigator Sponsor / Institution required) trial in compliance with the applicable regulatory requirement(s) required) required) CURRICULUM VITAE AND/ OR OTHER RELEVANT To document qualifications and eligibility to conduct trial and/ or provide DOCUMENTS EVIDENCING QUALIFICATIONS OF INVESTIGATOR(S) AND SUB-INVESTIGATOR(S) medical supervision of subjects NORMAL VALUE(S)/ RANGE(S) FOR MEDICAL/ LABORATORY/ TECHNICAL PROCEDURE(S) AND/ OR To document normal values and/ or ranges of the tests results TEST(S) INCLUDED IN THE PROTOCOL MEDICAL/ LABORATORY/ TECHNICAL PROCEDURES/ TESTS - certification or - accreditation or - established quality control and/ or external quality assessment or - other validation SAMPLE OF LABEL(S) ATTACHED TO INVESTIGATIONAL PRODUCT CONTAINER(S) INSTRUCTIONS FOR HANDLING OF INVESTIGATIONAL PRODUCT(S) AND TRIAL-RELATED MATERIALS (if not included in protocol or Investigator s related materials Brochure) SHIPPING RECORDS FOR INVESTIGATIONAL PRODUCT(S) AND TRIAL-RELATED MATERIALS CERTIFICATE(S) OF ANALYSIS OF INVESTIGATIONAL PRODUCT(S) SHIPPED To document competence of facility to perform required test(s), and support reliability of results To document compliance with applicable labelling regulations and appropriateness of instructions provided to the subjects To document instructions needed to ensure proper storage, packaging, dispensing and disposition of investigational products and trial To document shipment dates, batch numbers and method of shipment of investigational product(s) and trial-related materials. Allows tracking of product batch, review of shipping conditions, and accountability To document identity, purity, and strength of investigational product(s) to be used in the tria DECODING PROCEDURES FOR BLINDED TRIALS To document how, in case of an emergency, identity of blinded investigational product can be revealed without breaking the blind for the remaining subjects treatment (where required) (3 rd party if applicable) MASTER RANDOMISATION LIST To document method for randomisation of trial population (3 rd party if applicable) PRE-TRIAL MONITORING REPORT To document that the site is suitable for the trial (may be combined with ) TRIAL INITIATION MONITORING REPORT To document that trial procedures were reviewed with the investigator and the investigator s trial staff ( may be combined with

9 9 SOP Management of Essential Documents and Trial Folders PART 2: During the Clinical Conduct of the Trial [GCP 8.3] In addition to having on file the above documents, the following should be added to the files during the trial as evidence that all new relevant information is documented as it becomes available. Located in Files of Title of Document Purpose Investigator Sponsor / Institution INVESTIGATOR S BROCHURE UPDATES To document that investigator is informed in a timely manner of relevant information as it becomes available [annual updates are required for CTIMPs] ANY REVISION TO: To document revisions of these trial related documents that take effect during trial - protocol/ amendment(s) and CRF - informed consent form - any other written information provided to subjects - advertisement for subject recruitment (if used) DATED, DOCUMENTED APPROVAL/ FAVOURABLE To document that the amendment(s) and/ or revision(s) have been subject to IRB/ OPINION OF INSTITUTIONAL REVIEW BOARD (IRB)/ INDEPENDENT ETHICS COMMITTEE (IEC) OF THE FOLLOWING: - protocol amendment(s) - revision(s) of - informed consent form - any other written information to be provided to the subject - advertisement for subject recruitment (if used) - any other documents given approval/ favourable opinion - continuing review of trial (where required) IEC review and were given approval/ favourable opinion. To identify the version number and date of the document(s) REGULATORY AUTHORITY(IES) To document compliance with applicable regulatory requirements AUTHORISATIONS/ APPROVALS/ NOTIFICATIONS WHERE REQUIRED FOR: - protocol amendment(s) and other documents (where required) CURRICULUM VITAE FOR NEW INVESTIGATOR(S) (see ) AND/ OR SUB- INVESTIGATOR(S) UPDATES TO NORMAL VALUE(S)/ RANGE(S) FOR MEDICAL/ LABORATORY/ TECHNICAL PROCEDURE(S)/ TEST(S) INCLUDED IN THE PROTOCOL To document normal values and ranges that are revised during the trial (see ) UPDATES OF MEDICAL/ LABORATORY/ TECHNICAL PROCEDURES/ TESTS - certification or To document that tests remain adequate throughout the trial period (see ) (where required)

10 10 SOP Management of Essential Documents and Trial Folders Located in Files of Title of Document Purpose Investigator Sponsor / Institution - accreditation or - established quality control and/ or external quality assessment or - other validation (where required) DOCUMENTATION OF INVESTIGATIONAL (see ) PRODUCT(S) AND TRIAL-RELATED MATERIALS SHIPMENT CERTIFICATE(S) OF ANALYSIS FOR NEW BATCHES (see ) OF INVESTIGATIONAL PRODUCTS MONITORING VISIT REPORTS To document site visits by, and findings of, the monitor RELEVANT COMMUNICATIONS OTHER THAN To document any agreements or significant discussions regarding trial SITE VISITS - letters - meeting notes - notes of telephone calls administration, protocol violations, trial conduct, adverse event (AE) reporting SIGNED INFORMED CONSENT FORMS To document that consent is obtained in accordance with GCP and protocol and dated prior to participation of each subject in trial. Also to document direct access permission (see 8.2.3) SOURCE DOCUMENTS To document the existence of the subject and substantiate integrity of trial data collected. To include original documents related to the trial, to medical treatment, and history of subject SIGNED, DATED AND COMPLETED CASE REPORT FORMS (CRF) To document that the investigator or authorised member of the investigator s staff confirms the observations recorded (copy) (original) DOCUMENTATION OF CRF CORRECTIONS To document all changes/ additions or corrections made to CRF after initial data NOTIFICATION BY ORIGINATING INVESTIGATOR TO SPONSOR OF SERIOUS ADVERSE EVENTS AND RELATED REPORTS NOTIFICATION BY SPONSOR AND/ OR INVESTIGATOR, WHERE APPLICABLE, TO REGULATORY AUTHORITY(IES) AND IRB(S)/ IEC(S) OF UNEPECTED SERIOUS ADVERSE DRUG REACTIONS AND OF OTHER SAFETY INFORMATION NOTIFICATION BY SPONSOR TO INVESTIGATORS OF SAFETY INFORMATION were recorded Notification by originating investigator to sponsor of serious adverse events and related reports in accordance with GCP 4.11 Notification by sponsor and/ or investigator, where applicable, to regulatory authorities and IRB(s)/ IEC(s) of unexpected serious adverse drug reactions in accordance with GCP 5.17 and and of other safety information in accordance with GCP and (copy) (where required) Notification by sponsor to investigators of safety information in accordance with GCP INTERIM OR ANNUAL REPORTS TO IRB/ IEC AND Interim or annual reports provided to IRB/ IEC in accordance with 4.10 and to (original)

11 Located in Files of Title of Document Purpose Investigator Sponsor / Institution AUTHORITY(IES) authority(ies) in accordance with GCP (where required) SUBJECT SCREENING LOG To document identification of subjects who entered pre-trial screening (where required) SUBJECT IDENTIFICATION CODE LIST To document that investigator/ institution keeps a confidential list of names of all subjects allocated to trial numbers on enrolling in the trial. Allows investigator/ institution to reveal identity of any subject SUBJECT ENROLLMENT LOG To document chronological enrolment of subjects by trial number INVESTIGATIONAL PRODUCTS ACCOUNTABILITY To document that investigational product(s) have been used according to the protocol AT THE SITE SIGNATURE SHEET To document signatures and initials of all persons authorised to make entries and/ or corrections on CRFs RECORD OF RETAINED BODY FLUIDS/ TISSUE SAMPLES (IF ANY) To document location and identification of retained samples if assays need to be repeated PART 3: After Completion or Termination of the Trial [GCP 8.4] After completion or termination of the trial, all of the documents identified in GCP sections 8.2 and 8.3 should be in the file together with the following Located in Files of Title of Document Purpose Investigator Sponsor / Institution INVESTIGATIONAL PRODUCT(S) ACCOUNTABILITY AT SITE To document that the investigational product(s) have been used according to the protocol. To document the final accounting of investigational product(s) received at the site, dispensed to subjects, returned by the subjects, and returned to sponsor To document destruction of unused investigational products by sponsor or at site DOCUMENTATION OF INVESTIGATIONAL PRODUCT DESTRUCTION (if destroyed at site) COMPLETED SUBJECT IDENTIFICATION CODE LIST To permit identification of all subjects enrolled in the trial in case follow-up is required. List should be kept in a confidential manner and for an agreed upon time AUDIT CERTIFICATE (if available) To document that audit was performed FINAL TRIAL CLOSE-OUT MONITORING REPORT To document that all activities required for trial close-out are completed, and copies of essential documents are held in the appropriate files 11

12 8.4.6 TREATMENT ALLOCATION AND DECODING Returned to sponsor to document any decoding that may have occurred DOCUMENTATION FINAL REPORT BY INVESTIGATOR TO IRB/ IEC To document completion of the trial WHERE REQUIRED, AND WHERE APPLICABLE, TO THE REGULATORY AUTHORITY(IES) CLINICAL STUDY REPORT To document results and interpretation of trial (if applicable) 12

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