Trial Protocol. Version 1.2. Effective date: 18 May Dr Sarah Duggan, CTU Manager. V May 2010 Update web links.

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1 Trial Version 1.2 Effective date: 18 May 2010 Reviewed by: Approved by: Claire Daffern, QA Manager Dr Sarah Duggan, CTU Manager Revision Chronology: Effective Date Reason for change V May 2010 Update web links. V January 2008 Format change. Addition of text (protocol definition). V 1.0 March 2006 Update web-links Page 1 of 16

2 Trial 1. Purpose The purpose of this SOP is to outline the requirements that should be included in a clinical trial protocol. 2. Background A protocol is defined by both Medical Research Council (MRC) and International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines as A document that describes the objective(s), design, methodology, statistical considerations and organisation of a trial. All trials should have a full protocol regardless of whether they are funded or not. Each funding body will require a slightly different format for a protocol to be funded. 3. Procedure 3.1 Who? The protocol will be written by the Chief Investigator in conjunction with the trial statistician, the trial coordinator and other personnel as necessary. 3.2 When? The protocol is one of the first documents to be written. 3.3 How? Refer to details given below. Page 2 of 16

3 3.3.1 Preparation of the Trial Terminology A randomised clinical trial may be referred to as a trial or study, but one or other term should be used consistently throughout the protocol. For the purposes of this SOP the term trial will be used Front page of the The front page of the protocol should include: full protocol title acronym/trial code version number and date the stage (i.e. draft, amended or final) the EudraCT number (if applicable) the International Standard Randomised Controlled Trial Number (ISRCTN) Register reference number logo (if available) name of the funding body ethics committee approval date The protocol is final when it has been submitted to, and approved by, the appropriate ethics committee and the funding body/trial Steering Committee/Data Monitoring and Ethics Committee Content of the The list below covers the content of the protocol following the title page: Contact names and numbers Table of contents Main sections of the protocol: A. Background Epidemiology and burden of condition Existing knowledge Hypothesis Need for a trial Good Clinical Practice CONSORT recommendations B. Trial Design Trial summary Trial flow diagram Aims and objectives of the trial Outcome measures Power and sample size Eligibility Consent Recruitment and randomisation Page 3 of 16

4 Blinding Trial treatments Concomitant illnesses and medication Methods and assessments Adverse event management End of the trial C. Data Management Database and data management Data access and quality assurance Archiving of trial data D. Statistical Analysis Statistical analysis of efficacy, harms and health economics data E. Trial Organisation and Oversight Trial Supervision Regulatory authorities Project timetable and milestones Unblinding Collaborators responsibilities Indemnity/compensation/insurance Essential documents Monitoring and quality assurance policy Dissemination and publication Financial support F. amendments, where applicable G. References H. Appendices Contact names and numbers Name, phone number, address and office details of Trial Manager/coordinator Name, title and institute of: a. Sponsor b. Chief Investigator c. Co-investigators d. Trial statistician e. Health economist f. Specialist collaborators g. Trial steering committee h. Data monitoring and ethics committee Name and phone number to contact for randomisation problems Page 4 of 16

5 Name and address of any laboratories, technical departments or other institutions involved in the trial. Not required for standard laboratory tests done for the trial Background The background should detail the following: Epidemiology and burden of condition Existing knowledge This will detail systematic reviews, individual trials not included in reviews and other data that are relevant to the trial. In this section attempt should be made to summarise the published or unpublished trials in the form of a table giving information such as authors of trial, date of publication (if applicable, or state unpublished ), treatment, treatment doses, treatment period, number of participants, eligibility criteria, primary end-point and summary of results Hypothesis Need for a Trial In the light of the scientific evidence given, and other factors, the rationale will highlight the reasons why the trial is needed Good Clinical Practice State that the trial will be carried out in accordance with Good Clinical Practice (GCP) and in accordance with the following protocol. Trials of investigational medicinal products should follow the International Conference on Harmonisation (ICH) GCP guidelines available on the ICH website Much of the guidance in the ICH GCP is not applicable or appropriate for non-drug trials. All trials other than those of investigational medicinal products should follow the Medical Research Council (MRC) GCP guidelines available at Both documents are also available via the CTU website: CONSORT State that the trial will be reported in line with the CONSORT (Consolidated Standards of Reporting Trials) statement (Lancet 2001, 357: ). Up-to-date information on CONSORT revisions, downloadable check lists and flow chart are available on the CONSORT web site: or via the clinical trials unit website Page 5 of 16

6 3.3.4 Trial Design Trial summary Describe the overview of the trial. This may use some of the following terms: Multi-centre: a clinical trial conducted according to a single protocol but at more than one site, and therefore, carried out by more than one investigator. Cluster-randomised trial: a cluster randomised trial is one in which a group of participants are randomised to the same intervention together. Blinded: lack of knowledge of participants treatment allocation. Depending on the nature of the trial, various groups of people involved may be blinded, including the participants themselves, clinicians delivering the interventions, assessors of outcomes and the research team. Parallel group: a trial that compares two or more contemporaneous groups of patients, one of which receives the treatment of interest and one of which is a control group. Some parallel trials have more than one treatment group; others compare two treatment groups, each acting as a control for the other. Cross-over trial: a method of comparing two or more treatments or interventions in which participants or patients, on completion of the course of one treatment, are switched to another. Typically, allocation to the first treatment is by random process. Participants' performance in one period is used to judge their performance in others, usually reducing variability. Open-label trial: both the participant and investigator are aware of the treatment allocation. Equivalence trial: a trial with the primary objective of showing that the response to two or more treatments differs by an amount which is clinically unimportant. This is usually demonstrated by showing that the true treatment difference is likely to lie between a lower and an upper equivalence margin of clinically acceptable differences. Non-inferiority trial: a trial with the primary objective of showing that the response to the investigational drug is not clinically inferior to a comparative agent (active or placebo control). Factorial design: two or more treatments are evaluated simultaneously through the use of varying combinations of the treatments. The protocol should also state the duration of the trial and the expected duration of patient participation and follow-up Trial flow diagram Use a simple flow diagram to describe the trial as clearly as possible. This can be a prototype for the flow diagram that will be needed for the final publication and should be based on the CONSORT recommendations. The CONSORT website has a checklist and flow diagram for the reporting of clinical trials Page 6 of 16

7 3.3.5 Aims and Objectives of the Trial Primary aim This should be stated clearly Secondary aims Secondary aims might include aspects of quality of life (QOL) and health economics (if not already specified in the primary aims) Outcome Measures Outcomes should be broken down into: a) Efficacy: i) Primary (usually the one on which the sample size is calculated) ii) Secondary b) Safety: iii) Harm/adverse event data c) Others iv) Health economics (optional) v) Quality of Life (QOL) (optional) Provide a justification for the outcome measures to be used, particularly the primary measure. Give a clear definition of the outcomes, and the time-points at which these outcomes are to be measured. Give detailed definitions of outcomes in an Appendix, if necessary Power and Sample Size This section will include the estimated event rate, the size of treatment effect that should be detectable and the sample size. Number of patients to be enrolled. In multi-centre trials give the estimated recruitment for each site. Reason for choice of sample size, including estimates of drop-outs and crossover rates, and reflections on (or calculation of) power and clinical justification. The number of observed events required for maximum power should also be included. The level of significance. Details of the randomisation allocation should be stated (e.g. 2:1) if it is anything other than 1:1. Accrual rate. Number of potentially eligible people. Number expected to join the trial. Recruitment targets. Page 7 of 16

8 Eligibility Inclusion criteria These should be listed clearly Exclusion criteria These should be listed clearly Post-randomisation withdrawals and exclusions State that participants may withdraw from the trial treatment, and/or the whole trial at any time without prejudice. If a participant withdraws from the trial treatment, participants should be followed-up wherever possible and data collected as per protocol until the end of the trial. The only exception to this is where the participant also explicitly withdraws consent for follow-up. State what follow-up data are to be collected after patient withdrawal. Follow-up should continue unless the patient explicitly also withdraws consent for follow-up. State the procedures for attempted follow-up of patients lost to follow-up, e.g. linkage to disease registers or death registers. Participants may be withdrawn from the trial at the discretion of the Investigator and/or Trial Steering Committee due to safety concerns Compliance/contamination This section should include: A definition of what constitutes non-compliance. If required, this may be broken down further into a definition of a protocol deviation (any departure from the intended treatment and/or evaluation) and a protocol violation (something that was caused by or could have been prevented by the investigator and which materially affects the trial results). Any deviation from the protocol must be documented, stating the reason and date, the action taken and the impact for the participant and trial. State the methods to be used to ensure participant compliance with treatment schedules. State the methods to be used to avoid contamination. Contamination is defined as: the inadvertent application of an intervention being evaluated to people in the comparison group; or inadvertent failure to apply an intervention to people assigned to that intervention group. State the methods for recording compliance and contamination Page 8 of 16

9 3.3.9 Consent See SOP 7 Patient Information and Consent This section should include: The methods that will be used for obtaining informed consent. The length of time that will be allowed between the participant receiving information about the trial and giving informed consent. A list of information to be covered when obtaining informed consent The protocol should specify how the Investigator will inform participants if information becomes available that may be relevant to the participant s willingness to continue in the trial. This may mean that a revised written informed consent be obtained Recruitment and Randomisation The rate of accrual should be monitored and, if it falls appreciably below the projected level, the reasons should be identified and remedial actions taken in order to protect the power of the trial and alleviate concerns about selective entry and other aspects of quality. In a multi-centre trial these considerations apply to the individual centres. See SOP 9 Randomisation and Blinding State the method of randomisation. This needs to include method of random allocation sequence generation, factors used for stratification or minimisation. Randomisation should use a secure method of allocation concealment. The method should be stated. The preferred method of randomisation is a telephone or web-based system. State that, except in cases of cluster-randomised trials, the following sentence should always be included: informed written consent for entry into the study must be obtained prior to randomisation/enrolment. For cluster-randomised trials, refer to SOP 7 Patient Information and Consent. There should be a randomisation hotline number, and details of times when this number will/will not be available. Describe the pre-randomisation procedure to ensure that all eligibility criteria are met and that informed consent has been obtained. State the method to be used for flagging the participant s clinical notes about their inclusion in the trial Blinding See SOP 9 Randomisation and Blinding The protocol should state which groups of people involved in the trial will be blind to treatment allocation, and the mechanisms by which this will be ensured. This may include participants, clinicians delivering interventions or caring for participants, assessors of outcomes and personnel involved in running the trial. Blinding of outcome assessment should be considered in trials where participants and clinicians will not be blinded to treatment allocation. Often, a blinded outcome review committee is created to ensure unbiased assessment of outcomes. Page 9 of 16

10 Trial Treatments Describe the delivery of the interventions, i.e. the test and control. State how many doses/intervention delivery sessions should the patient attend in order to be considered compliant. Give details of other types of treatments that participants may seek whilst part of the trial Trials of Complex interventions State: The components of the intervention. The source of intervention products. Trial treatments: number, regimens, schedules, method of administration, duration, Personnel administering the intervention. The methods to be used to train the personnel delivering the intervention, and to ensure consistency of content and delivery across sites and over time. State how these will be monitored Trials of Investigational Medicinal Products Source of drugs, supplier, dose strength, tablets per package, storage conditions, ordering arrangements, arrangements for labelling drugs in doubleblind studies, arrangements for free or discounted open-label drugs. Trial treatments: doses, regimens, schedules, route of administration, duration. Dispensing: procedure, amounts given each time. Unused drug: state if unused drug is returned to sites, destroyed or returned to supplier. Accountability: describe methods used to document/log receipt of supplies, dispensing, returns to hospital, and returns to supplier. State if this is monitored. Medications allowed/not allowed before the trial, rescue or subsequent treatments allowed/not allowed. Concomitant medication: data required contraindicated medication, drug interactions and advice. Use in pregnancy and breastfeeding, precautions for women. Other precautions for men. Recommended dose reductions, interruption and permanent discontinuation for adverse events. Refer to toxicity grading included as an Appendix Concomitant Illnesses and Medication Concomitant illness: any illness that is present at the start of the trial. Concomitant medication: any medication, other than the trial product, that is taken during the trial, including screening and run-in periods. Details of concomitant illness and medication should be recorded at trial entry. Any changes in concomitant medication should be recorded at each visit. If the change influences the participants eligibility to continue in the trial, the Investigator must be informed. Page 10 of 16

11 Methods and Assessments Schedule of delivery of intervention and data collection Describe the timescale over which the intervention is delivered and the times at which data will be collected Withdrawal/discontinuation criteria State the mechanisms for ensuring that the participant does not meet any of the withdrawal/discontinuation criteria. State the criteria (if any) Laboratory assessments Define normal laboratory values as appropriate Adverse Event Management See SOP 17 Safety Reporting, Parts 1 and 2 Define adverse event (AE) and unexpected adverse event State which adverse events are exempt from recording Define a serious adverse event (SAE) Add requirements for reporting SAEs or other AEs e.g. regulatory requirements for expedited recording Define procedures and follow-up required after adverse events State the procedure to be used for the recording of adverse events at each visit following the randomisation visit. State the procedures to be used to inform the Data Monitoring and Ethics Committee (DMEC) of adverse events. State that a drug trial participant must be advised to notify the Investigator immediately if she becomes pregnant. The Investigator must report any pregnancy reported during the trial to the Sponsor. Pregnancy complications must be recorded as adverse event(s). If the infant has a congenital anomaly/birth defect, this must be reported and followed up as a serious adverse event End of the Trial See SOP 20 Closing a Trial Details of the expected end of the trial should be given, together with any plan for treatment of the participants after the trial if that differs from current practice Data Management Database and data management State which data are collected, when, and what will be done with them. Page 11 of 16

12 See SOPs 14 Clinical Trial Software Development and 15 Data Management Database (i) State that the database for the trial will be set-up by the computer programmer and all specifications (i.e. database variables, validation checks for the database, database screens) will be agreed between the programmer, statistician and the trial co-ordinator. (ii) State the procedure to enter the data (i.e. whether double-entry/singleentry). This is decided when the database is constructed. (iii)state that, if electronic databases are required on personal computers (PCs) external to the Clinical Trials Unit (CTU) (i.e. for collecting on-site data), then the computer programmer will make sure that the databases are compatible with the systems on site and the database is back-up accordingly. (iv) State that, in the case of interim analysis, the data will be frozen accordingly and following data will not be included from that point onwards in the interim report Data management (i) State that the case report forms (CRFs) will be designed by the trial coordinators, in conjunction with the Chief Investigator and statistician. (ii) Specify the mechanisms for chasing up missing data Data access and quality assurance Add statement on confidentiality and whether names or addresses will be disclosed to anyone other than the staff involved in running the trial. State if patients identified by code and/or initials only. State how laboratory specimens are identified. State if the Investigator must arrange for retention of study records on site in accordance with GCP. Specify in the protocol (or other document such as an Investigator s Agreement) if direct access to source data/documents will be required for trial-related monitoring or audit by the CTU, collaborating pharmaceutical companies, internal audit, regulatory authorities or ethics committees Archiving of Trial Data See SOP 23 Archiving of Trial Data Essential documents (see section ) must be archived for sufficient periods to allow for audit and inspection by regulatory authorities and should be readily available upon request. Each R&D department may have its own specific archiving requirements, and these must also be taken into consideration. Archiving applies to both the investigator sites and the central trial co-ordinating office. Page 12 of 16

13 Trials which are not to be used in regulatory submissions Essential documents from trials that are not to be used in regulatory submissions should be retained for at least five years after completion of the trial, or longer if required Trials to be included in regulatory submissions Essential documents should be retained until at least two years after the last approval of a marketing application in the EU, or longer if required. It is the responsibility of the Sponsor/someone on behalf of the Sponsor to inform the investigator/institution as to when these documents no longer need to be retained Statistical Analysis See SOPs 8 Statistical Considerations and 21 Statistical Analysis Plan Specify the methods to be used for the analysis of efficacy and harm data, and health economic data, if appropriate Trial Organisation and Oversight Trial supervision State if there is a Trial Steering Committee (TSC) and its composition and responsibilities. State that the TSC should have an independent Chairman. State if there is a Trial Management Group and its composition and responsibilities. State if there is a Data Monitoring and Ethics Committee (DMEC), whether it is independent and its responsibilities. Refer to any planned interim analyses and their frequency for the DMEC. State that the DMEC can recommend premature closure of the trial to the TSC, and can unblind the data if required. State if there is an Outcome Review Committee, its composition, which outcomes are reviewed and whether the reviewers are blinded. Detail the impact of the interim analyses upon the overall type I error probability. State the stopping rules, if any, and the involvement of the Data Monitoring and Ethics Committee (DMEC) Regulatory Authorities Clinical Trial Authorisation See SOP 5 Regulatory Approvals and Communications All clinical trials of investigational medicinal products must obtain a Clinical Trial Authorisation from the MHRA. Page 13 of 16

14 Trial Registration See SOP 28 Registration of Clinical Trials for Publication All trials should be registered with the International Standard Randomised Controlled Trial Number (ISRCTN) Register Project Timetable and Milestones Key events during the lifetime of the trial should be identified and dates by which they are to be achieved stated. Recruitment targets should be stated Unblinding In the case of blinded trials, a section should be included detailing the procedure and allowable reasons for breaking the blind. In most situations the only reason for breaking the blind should be for clinical management purposes ; all other reasons should be discussed and agreed with the Statistician Collaborators responsibilities Define the responsibilities of all collaborators Indemnity/compensation/insurance See SOP 10 Insurance for Clinical Trials State the arrangements made for injury to patients Essential documents to be held in a Trial Master File See SOP 11 Essential Documentation The Trial Master File should be set up at the beginning of a trial. The essential documents that make up the file should be kept in a secure but accessible manner and the purpose of each document should be clearly described. Essential documents serve a number of important purposes, they can help with efficient trial management, independent audit, close-out and archiving. All essential documents should be legible and accurate. The Trial Master File should be held at the principal site (Chief Investigator s office or Co-ordinating Centre) and copies of relevant documents should be kept at participating sites. It is anticipated that the European Commission will issue a detailed guideline that specifies the documents that should be included in the Trial Master File; however this is not yet available. For trials whose data may be required for a licensing application, it is recommended that Section 8 of the ICH GCP Guideline be followed Page 14 of 16

15 Some of the documents listed may not be available or applicable in many noncommercial trials. The appropriate documentation will vary according to the trial. Guidance on key documents may be found in Appendix 4 of the MRC Guidelines for Good Clinical Practice. Links to both ICG and MRC GCP guidelines can be found via the CTU website: Monitoring and Quality Assurance of Trial Procedures See SOPs 18 Monitoring and 19 Quality Control The purpose of trial monitoring as defined in Good Clinical Practice is to ensure that: 1. The rights and well-being of trial participants are protected, 2. The reported trial data are accurate, complete, and verifiable from source documents, and 3. The conduct of the trial is in compliance with the currently approved protocol/amendments, with GCP, and with the applicable regulatory requirements. During the course of recruitment to a clinical trial, the accumulating data must be monitored at frequent intervals to identify and facilitate the early remedial action of certain problems that may include, but not be limited to the following: 1. Problems with recruitment or data collection at any centre; 2. Problems in compliance with the protocol; 3. Problems in processing or entry of data; 4. Detection of fraud. It is a requirement of the EU Directive on GCP that clinical trials of medicines must stipulate in their protocol the policy for monitoring procedures. State the monitoring procedures to be used before, during and after the trial, and whether this is on-site monitoring or central monitoring (e.g. with procedures such as investigator training and meetings and extensive written guidance, which can assure appropriate conduct of the trial in accordance with GCP). Statistically controlled sampling is also deemed to be an acceptable method for selecting the data to be verified Dissemination and Publication See SOP 22 Publication and Dissemination Give the dissemination and publication policy in brief Financial support State who is funding the trial Amendments (where applicable) A list of protocol amendments is given in occurrence of: (i) date when the amendment was made and (ii) the page number/section in the protocol where the amendment occurred with (iii) reasons why the amendment was made. Page 15 of 16

16 Two different sorts of amendment may occur: those arising following the approval of the application by the funding body, and those arising after the commencement of the trial References Appendices Other appendices may include: Sample questionnaires, e.g. QOL scales Toxicity grading system Detailed information on treatment regimens Detailed pharmacology information or instructions Drug supply details Sample site investigator agreement, e.g. responsibilities of investigators Sample indemnity agreements with Trusts, e.g. guidelines on compensation Glossary of terms/definitions List of Abbreviations used AE Adverse Event CONSORT Consolidated Standards of Reporting Trials CRF Case Report/Record Form DMEC Data Monitoring and Ethics Committee EudraCT European Clinical Trials Database GCP Good Clinical Practice ICH International Conference on Harmonisation ISRCTN International Standard Randomised Controlled Trial Number MRC Medical Research Council QOL Quality of Life R&D Research & Development SAE Serious Adverse Event SOP Standard Operating Procedure TSC Trial Steering Committee Page 16 of 16

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