YOU ARE INSTRUCTED TO READ THE FOLLOWING THOROUGHLY BEFORE PROCEEDING TO

Title: OMB-MSOP 019 Processing Consent Forms and Patient Data Serial Number: OMB-MSOP 019 Version Approver: Enter name Version Number: 1.18 (Draft) Version Approval Date: [IN Version Effective: Two weeks from release Version Author: Gareth Bicknell Version Date: 08/08/2012 Area of Application: OMB Office Relevance: All OMB Staff Date Details of Review Version number No. of pages Name of Reviewer Next Review 22/02/12 08/08/12-12/09/14 New SOP formalising existing procedures Overhauled entire SOP in line with constantly-changing needs of the database; added adoption considerations 1.0 9 2.0 14 Huma Zafar, Nick Kenny, Gareth Bicknell Gareth Bicknell, Karolina Kliskey February 2013 Sep 2015 YOU ARE INSTRUCTED TO READ THE FOLLOWING THOROUGHLY BEFORE PROCEEDING TO UNDERTAKE THE METHODS DESCRIBED. UNDER NO CIRCUMSTANCES ARE THESE INSTRUCTIONS TO BE AMENDED OR ALTERED IN ANY WAY OTHER THAN BY THE AUTHOR / APPROVER. OMB-MSOP 019 Version 1.18 (Draft) Page 1 of 15

Table Of Contents 1 PURPOSE... 3 2 SAFETY INFORMATION... 3 3 DEFINITIONS... 3 3.1 OMB NUMBER... 3 3.2 ADOPTION... 3 3.3 MRN... 3 4 REQUIREMENTS & RESPONSIBILITIES... 3 4.1 GENERALLY... 3 5 REFERENCES & RELATED DOCUMENTS... 3 6 PROCEDURE... 4 6.1 FAILURE TO CONSENT... 4 6.2 SUCCESSFUL CONSENT USE OF OMB PATIENT FOLDERS... 5 6.3 ALLOCATION OF AN OMB NUMBER... 6 6.4 ELECTRONIC REGISTRATION OF A NEW OMB PATIENT FOLDER... 7 6.5 SEARCHING THE OMB PATIENT MONITOR DATABASE... 10 6.6 UPDATING WITHDRAWAL, DECEASED, AND FOLLOW-UP/CONTACT PREFERENCES... 10 6.7 UPDATING PROCEDURE DETAILS... 11 6.8 UPDATING OMB FOLLOW-UP ATTEMPTS... 12 6.9 DUPLICATED CONSENTS... 12 7 IMPLEMENTATION... 13 8 TRAINING REQUIREMENTS... 13 9 STAFF RECORD OF ACKNOWLEDGEMENT... 14 OMB-MSOP 019 Version 1.18 (Draft) Page 2 of 15

1 Purpose 1.1 The purpose of this SOP is to standardise the processing of consent forms and patient data, particularly at the point of OMB Patient Folder creation, so that every consent form can be linked to an OMB tissue sample or dataset (and vice versa). 2 Safety Information 2.1 Specific reference should be made to the University Occupational Health Service and their advice on Display Screen Equipment use with respect to eye strain and ergonomics. 3 Definitions 3.1 OMB Number 3.1.1 A number linking separate tissue samples/aliquots to a particular consent package. Equivalent to a trial number in a clinical trial. 3.2 Adoption 3.2.1 The process of accepting consents and material from protocols other than OMB s. Within OMB, these protocols are often termed external ethics. 3.3 MRN 3.3.1 Medical Record Number 4 Requirements & Responsibilities 4.1 Generally 4.1.1 All OMB office and laboratory team members are responsible for ensuring that the link between consent, data and tissue is retained. 5 References & Related Documents OMB-MSOP 019 Version 1.18 (Draft) Page 3 of 15

5.1 OMB-F 002 OMB Consent Form 5.2 OUH Patient Agreement to Investigation or Treatment 5.3 OMB-F 003 Sample Tracker and Laboratory Checklist 5.4 OMB-F 009 Sample Tracker and Laboratory Checklist Externally Approved Projects 5.5 PROT-NDORMS 01 Oxford Musculoskeletal Biobank Management 5.6 OMB-MSOP 014 Identification and Control of Non-Conformities 5.7 OMB-MSOP 024 Withdrawal of Donor Consent 5.8 OMB-MSOP 029 Initiation and Receipt of Follow-ups 6 Procedure 6.1 Failure to Consent NB OMB prefers to record a bare minimum of tracability data when a patient fails to consent, so that consenters know whether or not to approach the patient again. However, it is essential that only a bare minimum of data is recorded, in order to avoid accidental use of unconsented data into a research context. 6.1.1 Open the OMB Patient Monitor Database. Trust it, if asked to. 6.1.2 Click the Open Non-Consents Form button. 6.1.3 Provide the following details: The date of failure to consent A reason for the failure (e.g. patient declined, no approach possible, appointment cancelled, patient ineligible) Your initials The MRN and, if available, the NHS number of the patient The patient s date of birth OMB-MSOP 019 Version 1.18 (Draft) Page 4 of 15

6.1.4 The record will be added when the form is closed. 6.2 Successful Consent Use of OMB Patient Folders NB A new OMB Patient Folder must be created each time a new OMB Number is allocated, i.e. every time a new patient care pathway is followed (as per OMB Management Protocol, PROT-NDORMS 01), or as determined by the adopted study s protocol. For OMB consents, when tissue originates from an episode of continuing treatment or a consent confirmation during continuing treatment, no new folder is required the existing one should be used. 6.2.1 OMB Patient Folders contain an archive of all paperwork relevant to a particular OMB Number, and folders are coloured according to the joint or pathway. The colour scheme is as follows: Red Operative Hip (non-oncological) Green Operative Knee (non-oncological) Blue Operative Shoulder (non-oncological) Yellow Operative Elbow (non-oncological) Black Oncological Orange Non-operative RA, Spine, Ankle, Wrist, Other 6.2.2 On receipt of a consent form (whether OMB-F 002 or other), check for the following: In all cases, it must have been correctly signed and dated by the patient. In all cases, it must have been correctly signed and dated by the person obtaining consent. The version of the form should be one appropriate to the date of signing. All required boxes should have been initialled in the patient s handwriting as per relevant study protocol and patient wishes. NB some non-omb protocols may deem ticks acceptable. OMB-MSOP 019 Version 1.18 (Draft) Page 5 of 15

For non-omb consents being adopted, there must be a positive indication that samples and/or data can be stored for unspecified future research. For OMB-F 002 and NHS consent forms, the patient s name, NHS number and/or MRN and preferably a date of birth and gender must have been recorded. The name must match that of the person giving consent. For OMB-F 002, the person obtaining consent should be an approved OMB consenter (i.e. signed off by the OMB Manager). 6.2.3 If there are any failures of the above conditions, report the matter immediately to the OMB Manager for consideration before continuing. 6.2.4 If the consent form is acceptable, secure it in the folder, along with any other relevant paperwork received. Consent forms should remain at the back of the folder throughout its lifespan in order to enable rapid consent audit at any time. 6.2.5 If the folder is a new one, secure a Sample Tracker and Laboratory Checklist into the front. There are two versions: OMB-F 003 (Sample Tracker and Laboratory Checklist), used for patients consented using OMB-F 002 (OMB Consent Form) or the OUH Patient Agreement to Investigation or Treatment ( NHS consent ) OMB-F 009 (Sample Tracker and Laboratory Checklist Externally Approved Projects), used for consents under non-omb protocols (i.e. consents for adoption) 6.2.6 The Sample Tracker should remain at the front of the folder throughout its lifespan in order to allow rapid identification of the consent origin and care pathway. 6.2.7 Any other documentation should be sandwiched between these forms in reverse chronological order (i.e. most recent first), as per standard NHS practice. 6.3 Allocation of an OMB Number OMB-MSOP 019 Version 1.18 (Draft) Page 6 of 15

NB To avoid excessive bureaucracy, it is very important to allocate a new OMB Number only when the consent requires it. Always use the database to check for existing consents recorded against any particular patient, and always adhere to the OMB Management Protocol when classifying a consent. If you are in any doubt, consult the OMB Manager. 6.3.1 If you need a new OMB Number, locate the next available set of 20 stickers from the rolls in the OMB office. Avoid tearing off more sets than you are actually going to use, because all need to be accounted for. NB stickers are custom pre-printed in sets of 20. The format of each number is OMB YY/NNNN, where NNNN is a number in sequence from 0001-9999, and YY reflects the current financial year (e.g. 11 for 01/04/2011-31/03/2012). 6.3.2 Stick one sticker into the indicated box on the consent form (or somewhere prominent if there is no box). 6.3.3 Stick one sticker to the top of the front-facing folder spine, orientated such that the bottom of the text points to the right of the folder: OMB XX / NNNN Lorem ipsum dolor sit amet, consectetur adipisicing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris 6.3.4 Using a stapler, attach the strip of remaining stickers to the Sample Tracker. 6.4 Electronic Registration of a New OMB Patient Folder NB It is very important to register a new OMB Patient Folder as soon as possible, and preferably on the day of consent. This allows other researchers to check the consent, thus avoiding over-burdening patients with consent attempts. It also avoids breaches of the OMB Management Protocol through accidental re-use of a consent beyond its limit. 6.4.1 Open the OMB Patient Monitor Database. Trust it, if asked to. OMB-MSOP 019 Version 1.18 (Draft) Page 7 of 15

6.4.2 Click the Add Record button. 6.4.3 At the top of the page, enter the following data: The OMB Number The NHS number, if available (the special number, 000-000-0000, is valid and should be entered) The patient s date of birth, if available The patient s gender The category of procdure or treatment Any relevant MRN (i.e. old or new), if available 6.4.4 On the Consent tab, enter the following data: The Date of consent The Version of consent form used (contact the OMB Manager if the required version is not available) The Location of consent, if at the OUH and if known The Consenter Initials if the consent is on OMB-F 002, or else select NHS for NHS consenters, or PROJ for consenters operating under external ethics The OMB Study reference for which consent has primarily been taken (if the consent is on OMB-F 002 or an NHS consent form), or the OMB reference under which OMB is adopting the consent (if being adopted), or nothing (otherwise) Any relevant comments, including any further study-specific consent comments 6.4.5 Tick the Critical Initials Missing box only if: The consent form is OMB-F 002, and OMB-MSOP 019 Version 1.18 (Draft) Page 8 of 15

Initials are missing from any statement except follow-up, contact-for-futurestudies, or implants when no implant is being removed. 6.4.6 Tick the Opt-out Preferences Unclear box only if The consent form is OMB-F 002, and Initials are missing from the follow-up and/or contact-for-future-studies statements, and There is also no clear indication elsewhere that the follow-up and/or contact is unwanted. 6.4.7 Tick the No Data Consent box only if the consent form does not include an explicit acknowledgement of consent to collect data from medical records (usually older NHS versions). NB this may be because the statement does not exist, or because the patient has failed to circle any option(s), or because the patient has circled one or more negative options. 6.4.8 Ensure the No Contact for Other Studies box has auto-ticked if the consent form does not specifically permit OMB to contact the patient for future studies. 6.4.9 Ensure the No Further Follow-up box has auto-ticked if the consent form does not specifically permit OMB to follow the patient up. 6.4.10 On the Procedure Details tab, enter the following data: The Clinician involved in the expected or actual procedure, if known The Expected Side, if known and available (or the Actual Side, if more appropriate) The Expected Procedure, if known and available (or the Actual Procedure, if more appropriate) The Expected Diagnosis, if known and available (or the Confirmed Diagnosis, if known) OMB-MSOP 019 Version 1.18 (Draft) Page 9 of 15

6.4.11 The remaining tabs are for recording other documentation and data available, and they should be completed as the information is added to the folder (usually at a later date). 6.3.8 Click the Save button to commit the record to the database, or use your keyboard s Esc key to undo changes prior to closing the form. 6.5 Searching the OMB Patient Monitor Database 6.5.1 Click the box representing the field that you wish to search. 6.5.2 Click the binoculars button. 6.5.3 Enter the search criterion into the Find What box, and click the Find Next button. NB a much broader search capability may be attained by selecting OMB Master Form from the Look In dropdown box and/or changing the value in the Match box. 6.5.4 Watch for changes being displayed in the form in the background. If a record is found, check that the details match those you are expecting, e.g. procedure. (You may switch data tabs with the Find window still open.) If there is not sufficient matching, click the Find Next button again. 6.5.5 Repeat the previous step until there is sufficient matching, or until a not found message is displayed. 6.5.6 Close the search form. 6.6 Updating Withdrawal, Deceased, and Follow-Up/Contact Preferences 6.6.1 If a patient indicates that s/he wishes no further follow-up, tick the No Further Follow-up tick box, and record the pedigree of this information in the consent notes (e.g. the date and a reference to a phone-call). 6.6.2 If a patient indicated that s/he wishes no further contact for other studies, tick the No Contact for Other Studies tick box, and record the pedigree of this information in the consent notes (e.g. the date and a reference to a phone-call). OMB-MSOP 019 Version 1.18 (Draft) Page 10 of 15

6.6.3 If a patient withdraws consent, enter the date of withdrawal and initials of the OMB Team member recording the withdrawal in the boxes provided by the main database form. You must then follow OMB-MSOP 024 (Withdrawal of Donor Consent). 6.6.4 These features ensure that patients wishes are respected. 6.6.5 If a patient is deceased, tick the Deceased tick box and ensure that the No Further Follow-up and No Contact For Other Studies tick boxes are also ticked. Also record the pedigree of this information in the consent notes (e.g. the date and a reference to a phone-call). 6.6.6 In all cases, file any provided documentation in the relevant OMB Patient Folder(s). If no documentation is available, best practice is to file your own dated note as a back-up to the electronic record. 6.7 Updating Procedure Details NB This is essential for correct follow-up of patients. 6.7.1 Click the Procedure Details tab. 6.7.2 Update the fields as follows: Actual Side the side of the procedure actually performed on the patient Actual Procedure the name of the procedure actually performed on the patient Confirmed Diagnosis the diagnosis that was actually given Actual Admission Date the date of actual operative admission Procedure Comments e.g. reason why operation was not performed 6.7.3 If the Actual Procedure has changed from the Expected Procedure, you must ensure that the Category matches the Actual Procedure. Even if the project for which the patient was consented has not asked for follow-up, this is very important to avoid OMB sending out incorrect letters and questionnaires. OMB-MSOP 019 Version 1.18 (Draft) Page 11 of 15

6.8 Updating OMB Follow-Up Attempts 6.8.1 This is covered by OMB-MSOP 029 (Initiation and Receipt of Follow-ups). 6.9 Duplicated Consents 6.9.1 If you find a duplicate OMB consent for the same patient-side-joint, consult the OMB Manager for a decision on whether/how to merge OMB Patient Folders. 6.9.2 Folders from other studies monitored by the OMB Patient Monitor database must never be merged under any circumstances. 6.9.3 As a guide to merging decisions: If both folders refer to collected tissue or follow-ups, record the duplication of consent in the OMB Patient Monitor, stating that all future references should be made to [the newer OMB Number], and earlier references may exist as [the older OMB Number]. Place a sheet of paper stating the same principle into each folder. In the case of the older OMB Number folder, this sheet should be at the very front to prompt users not to add to the folder again. (This is equal folder precedence.) If one folder refers to collected tissue or follow-ups, but the other refers to neither, fully merge the documentation of the no-tissue/follow-ups folder into the documentation of the with-tissue/follow-ups folder. Retain the empty folder. Record the merger in both OMB Numbers in the OMB Patient Monitor database, and state its reason. Place a sheet stating the merger and its reason into both the newly merged folder and the newly empty folder. (This is folder content precedence.) If neither folder refers to collected tissue or follow-ups, and one consent is on a more recent consent version than the other, merge the earlier folder into the later folder. Record the merger in both OMB Numbers in the OMB Patient Monitor database, and state its reason. Place a sheet stating the merger and its reason into both the newly merged folder and the newly empty folder. (This is consent version precedence.) OMB-MSOP 019 Version 1.18 (Draft) Page 12 of 15

If neither folder refers to collected tissue or follow-ups, and both consents are on the same version, merge the later folder into the earlier one. Record the merger in both OMB Numbers in the OMB Patient Monitor database, and state its reason. Place a sheet stating the merger and its reason into both the newly merged folder and the newly empty folder. (This is consent date precedence.) 6.9.4 Any variation from the above policies should be recorded as a Non-Conformity, as per OMB-MSOP 014, and a copy of the resulting note placed in both folders. 7 Implementation 7.1 This SOP describes the procedure for setting up an OMB Patient Folder and registering it on the database, and for updating the database in certain circumstances. 7.2 Although not affecting the actual OMB-critical data and tissue, this SOP describes how OMB intitiates the mechanism tissue/data-consent linking more rapidly than by paper archive alone. This SOP may therefore be referenced by SOPs covering a wide variety of scenarios, ranging from standard OMB samples to imported diagnostic samples, hosted samples to non-critical data. 7.3 Care should be taken when modifying this SOP to ensure that it still works in all situations. 8 Training Requirements 8.1 Basic office and computer training. Computer skills may be enhanced through course available from the University of Oxford or the OUH NHS Trust. OMB-MSOP 019 Version 1.18 (Draft) Page 13 of 15

9 Staff Record Of Acknowledgement 9.1 I understand the contents of this document. 9.2 I have received the training appropriate to the procedures and feel competent to undertake them. 9.3 My supervisor agrees that I am able to perform the work covered by this SOP. 9.4 I understand that further on the job or other training supervision may be required before working independently. 9.5 I understand that I may discuss my needs with my manager. Trainee Trainer (if applicable) Name Position Signature Date Signature Date OMB-MSOP 019 Version 1.18 (Draft) Page 14 of 15

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