Imperial Clinical Research Facility User Guidelines

Transcription

1 Imperial Clinical Research Facility User Guidelines

2 Imperial CRF Users Guidelines The NIHR/Wellcome Trust Imperial CRF is a mul user facility for clinical research involving both pa ents and healthy volunteers. The role of all CRF staff is to support clinical research, ensuring that all studies comply with regulatory policies and are undertaken to a high standard. The staff help undertake studies within the facility whilst ensuring the safety and wellbeing of all research par cipants. The following guidelines have been developed to enable research to be conducted under op mum condi ons with standards for par cipants and professional colleagues being maintained. We would like to facilitate your research study in a safe and efficient working environment, ensuring that all studies comply with Interna onal Conference on Harmonisa on Good Clinical Prac ce (ICH GCP); Research Governance Framework for Health and Social Care (DoH) 2005, Medicines for Human Use (Clinical Trials) Regula ons 2004 and its amendments, Human Tissue Act 2004 and all JRCO and Imperial College Healthcare NHS Trust (ICHNT) health and safety measures. The success of a research project in the CRF relies on collabora ve planning and effec ve communica on. This will ensure the delivery of reliable research data to support high quality publica ons. How the CRF works The CRF currently supports studies during the core hours of Monday to Friday between 8am and 8pm (6pm on Fridays). We also offer overnight cover Monday to Thursday night, provided we receive sa sfactory no ce. Addi onal hours, including weekends, can be arranged on a case by case basis. Studies are approved by the Protocol Review Board (PRB) which is usually held on the second and last Thursday of every month, or the Phase I PRB, held on the last Thursday/month (phase I studies only). The current versions of the applica on form and policy are available from the CRF General Manager or can be downloaded from the CRF website. The form needs to be sent to us at least a week before the mee ng. During PRB approval, each study is allocated to a named person who acts as the Study Contact. The role of the Study Contact is to ensure that the research team have the required training to undertake a research project in the CRF, to make sure that the CRF have copies of all essen al documents before the study starts and to liaise with the research team once the study has started to ensure that we are aware of any amendments and are regularly updated with e.g. recruitment figures, SAEs and protocol viola ons (see applica on policy for further informa on) Studies can commence when R&D, Research Ethics Commi ee (REC) and any other relevant approvals are in place and when the CRF study set up process is complete, including CRF induc on of all research staff. Site ini a on visits (SIVs) including the Imperial CRF team and pharmacy where relevant must be conducted for all CTIMPS before the study starts. A mutually agreed start date will be arranged. 2

3 Research Governance Protocols, Amendments / Changes to Protocols All ac vity must comply with ICHNT R&D policies, JRCO and the CRF s SOPs where applicable. All projects must have wri en protocols to which the inves gator must adhere. We require wri en evidence of REC, R&D and any other relevant approvals (e.g. MHRA), including approvals for all substan al amendments. Please note that all approvals, including R&D approvals, for substan al amendments must be in place before the amendments are implemented. Your Study Contact should be informed of all proposed amendments as soon as possible. The REC must be informed if there is a change of PI. Although it is not mandatory to no fy the REC of changes in co inves gators or minor protocol amendments, the CRF must be informed of such changes to ensure effec ve ongoing facilita on of the studies. Consent and Pa ent Notes To ensure that your consent forms and pa ent notes conform to GCP and legisla on, please comply with the following points: Signed consent must be given before ANY research ac vi es are undertaken, i.e. anything that comes outside normal rou ne care. All study par cipants must have ICHNT pa ent notes, including healthy volunteers. Our CRF Administrators can generate pa ent numbers, notes and labels if required, provided adequate no ce is given. All pa ent informa on sheets (PIS) and consent forms must be printed on ICHNT headed paper Signed consent and the PIS must be inserted in the consent sec on of the pa ent notes. Two copies should be made: the top copy should go in the trial master/site file, one copy in the pa ent notes and one to the pa ent (unless otherwise specified in the protocol). The pa ent notes must be completed for every visit and must state when the consent was signed and which procedures were carried out. On subsequent visits par cipants should also be asked if they are happy to con nue with the study, and this should be noted (e.g. pa ent happy to con nue) Adverse Events/ Serious Adverse Events/ Serious Adverse Reac ons If an Adverse Event (AE), Serious Adverse Event (SAE) or Serious Adverse Reac on (SAR, including SUSARs) should occur whilst a par cipant is taking part in a CRF hosted study, the researcher should complete the appropriate documenta on and escalate as appropriate. Notable significant clinical events for CTIMPs involving healthy volunteers should also be recorded on CRF Manager, our scheduling and study management so ware system, so that these are easily accessible during subsequent visits. If the study is self contained, let our Data Manager know of any clinical events. All SAEs must be followed to comple on. Copies of all SAEs for CTIMP studies should be forwarded to the CRF Clinical Trials Monitor 3

4 Standard Opera ng Procedures (SOPs) PIs and researchers are expected to comply with all relevant CRF SOPs when using the CRF. CRF SOPs and forms can be accessed from any Trust computer via EQMS. This is a document management system for which you will be given password protected access and will provide us with a record of SOPs you have accessed. You are required to read the relevant SOPs as detailed in the Appendix to SOP ICRF OP03.03 Training records. Copies of SOPs are also held in folders in the CRF (one in the hot desk room and one in the staff/researchers lounge). Study specific SOPs should be sent to our QA Manager who will check they are GCP compliant before they are implemented in the CRF. Bookings All subjects should be booked using the single or mul ple admission booking forms. These should be completed in full and returned to the CRF Administrators, at least 48hrs prior to the proposed visit, either by or encrypted e mail ONLY) to Imperial.CRF@imperial.nhs.uk, fax or hand delivery. Bookings will be reviewed at 3pm daily and reserved on a first come first served basis. You will be no fied if your booking cannot be accepted, generally due to lack of nursing support or space. You can only make bookings against a study following PRB approval and receipt of all documents as outlined in the study applica on policy. Medical Cover The CRF can provide medical cover during core medical working hours by arrangement. Outside these hours medical cover is the responsibility of the PI or their delegate. The covering clinician must be aware of the details of the study, any procedures to be performed and the nature of any an cipated clinical problems. Addi onal on site medical PI or PI delegate medical cover may be required for First Time in Human (FTIH) trials. Please refer to the relevant SOP and the PRB approval documents for details. The PI or named designate must ensure clinical cover on the study day for the required period of me including out of hours cover if dosing occurs late in the day. The name of the covering clinician and their bleep/pager/extension number must be provided to the allocated nurse. Where the Imperial CRF risk assessment has determined that there should be a medical presence in the unit, this will need to be in place prior to the commencement of study interven ons. If agreed medical cover is not in place, research interven ons will be suspended un l sa sfactory cover is present. Contracts, induc on and training Ethics guidelines s pulate that the Principal Inves gator (PI) is responsible for the conduct of the study at his/her site, and for the study team. We provide mandatory induc on to the CRF which all researchers, nurses and students undertake prior to working in the unit. It is the responsibility of the PI to ensure that all study team staff have either substan ve contracts or a Licence to A end with the Trust prior to undertaking clinical research ac vity. The PI may delegate ac vi es to members of the team, but only if they are appropriately qualified and trained including protocol specific training. Delega on must be recorded in a delega on of authority log. Training should be arranged through the team member s manager or the PI. Any 4

5 specific equipment training should be arranged by the individual. GCP training (within the previous two years) is also mandatory. If you are unsure of what training you need, please discuss this with the study contact. Safety in the CRF All researchers should follow ICHNT Health and Safety policies for the safety of themselves and others. Physical Security All researchers must wear a College iden fica on badge when in the CRF. Researchers may not access or use any part of the facility when no CRF staff are present except in excep onal circumstances, when specific permission has been given in advance by the CRF General Manager, Lead Nurse, or delegate. All facility users should ensure they are familiar with the College s Lone Worker policy and have completed the forms if lone working is required. IT Security The following guiding principles should always be adhered to: Person iden fiable data should normally be stored on the Trust network. Storing or copying data to a mobile device should only be undertaken where mobility is essen al Person iden fiable data should never be stored on a non encrypted mobile device (memory s ck, portable hard drive or laptop) Person iden fiable data should never be stored on a computer not owned and controlled by ICHNT. College computers are not considered appropriate for saving pa ent iden fiable data. Person iden fiable data should never be sent using non secure addresses. Only NHS Mail may be used to send this type of data outside the Trust. You must not send pa ent iden fiable informa on to or from imperial.ac.uk accounts Resuscita on Two resuscita on trolleys are located in the corridors. Resuscita on equipment is checked daily during standard working days (i.e. not weekends, bank holidays or CRF training days). The CRF is covered by the ICHNT Resuscita on Team. To contact the team dial 2222 and give your loca on and the type of emergency; instruc ons for the exact wording required are detailed on orange cards next to each phone in the clinical area. You will also need to contact College security immediately to ask them to open the doors to allow access to the Crash Team; again instruc ons are detailed on the cards. Equipment The CRF has a wide range of specialist equipment which we maintain. Many researchers have specialist equipment that is unique to their field of interest. Inves gators must be aware that equipment which is not compliant with safety standards will not be accepted into the CRF. Researchers who need to bring their own medical/electrical equipment into the CRF for use in studies should inform the Lead Nurse prior to the start of the study, or the Lab Manager for laboratory equipment. 5

6 Equipment must be clearly labelled, showing the department of origin, study number and contact name. Unless equipment is formally accepted as a dona on to the CRF, the PI s department con nues to be responsible for the equipment s safety i.e. electrical tes ng, service and maintenance. Medical electrical equipment used in close proximity to par cipants must have passed the relevant tests currently undertaken by ICHNT Clinical Engineering Department, and evidence of this must be provided. Trust equipment will have an asset number a ached. Equipment Failures All CRF equipment failures or maintenance problems should be reported immediately to the Lead Nurse or Nurse in Charge (clinical equipment) or the CRF Administrators (non clinical), so that they can resolve the issue. Infec on Control Researchers must adhere to ICHNT Infec on Control policies and use the protec ve equipment provided (e.g. plas c aprons, gloves, goggles) where appropriate. Please see a member of the CRF staff with any ques ons or concerns. Labelling of sample containers may only be undertaken in clinical areas to limit the risk of accidental contamina on Laboratories Access will only be granted to researchers who have undergone Laboratory induc on and read and understood the laboratory Code of Prac ce and the relevant lab SOPs. As a minimum, researchers MUST wear gloves and aprons while working at the bench or using any equipment in the laboratories. Further PPE, such as eye protec on and full lab coat, must also be worn if specified by the risk assessment.. No food or drink is allowed in the lab areas at any me. Researchers are responsible for ensuring that they clean up any equipment/spillages a er using the facility. These should also be reported to the Lab Manager or core staff member The lab has limited freezer capacity at 20 C and 80 C. We offer short term storage, but all samples must be stored and managed in accordance with GCLP and as outlined in the specific SOPs. This will require sample specifics to be recorded into a LIMS database to allow their iden fica on and traceability, or researchers will not be allowed to use this resource. Samples should be removed by research teams as soon as possible (preferably within 2 weeks). Freezers temperatures are monitored con nuously, and a 24 hour alarm call out system is in place. Researchers are responsible for risk and/or COSHH assessment of equipment and chemicals brought into the ICRF labs. These should be made available to the Lab Manager in advance. 6

7 Imperial CRF Facili es Tidiness The CRF is a mul user facility, so please keep the areas you are using clean and dy, and ensure they are le this way when you have finished with them. Please inform the Clinical Research Prac oner if clinical stocks are running low in either the clinical areas or the stock room. Hot desk room and Researcher/staff lounge e que e Desks are available in the Hot Desk room and researcher/staff lounge or researchers, but only those that have been marked as such. Please ensure that you comply with the following: PCs may not be reserved The PCs are for the use of researchers who have volunteers in the unit at the me. Due to limited availability, you may not use the hot desk room when you do not have par cipants present. PCs are to be used for study related work only. Log out as soon as you have finished or if you will be away from the desk for more than 15 min. Desks must be le clear a er use, including mugs etc Avoid lengthy discussion in this room; please respect others who are trying to work (hot desk room only) Do not remove anything from other desks Do not unplug PCs for any reason No hot or strong smelling food may be eaten in these areas Researchers may use spare filing drawers for temporary storage of study documents while they are in the CRF or if agreed in advance. We only have very limited storage in this room, and it is primarily for the use of CRF staff. Handbags etc may be kept in any empty filing drawers while users are in the CRF Food and Drink A supply of drinks and snacks are available for study par cipants. Hot meals and sandwiches can be provided if requested. If required by the study protocol, specially prepared food can be arranged and this should be agreed and arranged in advance via the study contact. Researchers are welcome to use the staff room facili es and kitchen provided they leave them as they would expect to find them. Users are responsible for washing up their own crockery/cutlery. Diet Kitchen The diet kitchen is to be used for preparing food for research studies only. All users are expected to leave the kitchen in a clean and dy condi on. Phones Trust phones are for business use only and must not be used to make personal calls. Staff call cards can be purchased in Trust recep on if you need to make a personal call Par cipant ipads and laptops Laptops and ipads are available from recep on for volunteer use. It is the researchers responsibility to ensure that these and their power cables are returned at the end of the visit. 7

8 Visitors Visitor passes are required for the following groups. Visitor passes can be obtained from recep on Any staff or students who do not have swipe card access Par cipants friends/family External contractors General visitors to the facility Other Issues Publica on The CRF and NIHR must be acknowledged in any publica ons/abstracts/posters arising out of work undertaken in the facility. This will contribute to the metrics which form part of our reports to NIHR, and ensure subsequent funding to support your studies. NB: this is a cri cal metric and so noncompliance may result in withdrawal of support for your future studies NIHR have issued a required text for inclusion in all publica ons as follows: "This paper presents independent research funded by [name of funder] and carried out at the NIHR/ Wellcome Trust Imperial Clinical Research Facility. The views expressed are those of the author(s) and not necessarily those of the (name of funder), the NHS, the NIHR or the Department of Health. Withdrawal of support The CRF reserves the right to suspend work on any project conducted in the facility should staff become concerned about par cipant or staff safety or research governance e.g. viola on or devia on from study protocols. Support may also be withdrawn if you do not return your annual renewal request. Feedback We would welcome your feedback on the CRF service, and if you would like to provide any comment please contact the CRF staff with your sugges ons. 8

9 Key contact details Address CRF General Manager Karen Mosley: Lead Nurse Shokri Othman: QA Manager Marion Watson: Laboratory Manager Damian Johnson: CRF Administrators Jeanne e Davies and Elizabeth O Brien: Imperial.CRF@imperial.nhs.uk Tel Fax NIHR/Wellcome Trust Imperial CRF, Imperial Centre for Transla onal and Experimental Medicine, Imperial College Healthcare NHS Trust, Hammersmith Hospital, Du Cane Road, London W12 0HS Tel We acknowledge the kind permission given by NIHR/Wellcome Trust Cambridge CRF to adapt their User Guidelines Version 1 03/04/2014 9