Cancer Research UK Clinical Trials/Research Unit Glasgow Quality System BEATSON WEST OF SCOTLAND CANCER CENTRE POLICY ON THE AWARENESS AND TRAINING OF STAFF MANAGING PATIENTS WITHIN THE CONTEXT OF A CLINICAL TRIAL To: All staff involved in managing patients on clinical trials within NHS Greater Glasgow and Clyde Health Board From: Clinical Trials Executive Committee Date: 08 Oct 2015 1. INTRODUCTION This policy document describes the levels of awareness or training in Good Clinical Practice (GCP) required for staff who manage patients on clinical trials conducted within NHS Greater Glasgow and Clyde Health Board (NHSGG&C) which have been approved by the Beatson West of Scotland Cancer Centre s Clinical Trials Executive Committee, based on their levels of involvement with trial patients. It also describes the level of training in the individual trial protocol that is required by these staff. 2. BACKGROUND All staff who manage patients in clinical trials must understand what awareness and/or training they require to carry out their role. There are two specific areas of awareness and training; the principles of GCP and the specific protocol(s) for the trial(s) on which they are working. The levels of awareness or training in each of these domains will depend upon the nature of the activities that they are delegated to perform. These levels are targeted at all individuals who may perform activities within clinical trials, e.g. radiographers, pharmacy staff, auxiliary staff, doctors, nurses. 3. LEVELS OF TRIAL INVOLVEMENT There are 3 levels of involvement for staff that manage trial patients within the BWoSCC: Level 1: Activity that is specified in the trial protocol, but which is conducted in exactly the same way as in routine care, e.g. recording of BP or ECG, and is conducted by an individual who would normally perform these activities during routine care. Level 2: Activity that is specified within the trial protocol and is unique to the trial, but which is within the normal remit of clinical responsibility for that member of staff. For example: o The administration of IV Investigational Medicinal Product (IMP) by a nurse trained in the administration of IV drugs. o Following an approved local dispensing procedure by pharmacy staff. In practice, there are few other examples. Level 3: Activity that is trial-specific and does not fall within the normal remit of clinical responsibility for the individual. Many activities performed by sub-investigators, research nurses and lead pharmacy contacts will fall into this category. Appendix II contains a list of examples of duties that would be performed at the above levels. 4. LEVELS OF AWARENESS/TRAINING Page 1 of 5 Version 2: 08 Oct 2015
For each activity level, there are corresponding degrees of training required in GCP and also trial-specific training: Level 1: 1. GCP training a brief GCP awareness document will be available to these staff members to consult in their area of activity, but no record will be kept as to whether or not this document has been received by individuals. 2. Trial-specific training no trial specific training is required, and these staff will not be listed on trial delegation logs or training logs. The responsibility for protocol compliance will lie with the member of the trial team who is instructing the individual to carry out this activity. The fact that the individual carrying out the activity does so as part of clinical job is considered sufficient evidence of training in the activity. The individual is not delegated to perform any activity within the trial that is not part of their everyday practice. Level 2: 1. GCP training abbreviated training will be provided to all relevant staff prior to undertaking trial activity. For Example: For nurses administering IV IMPs, this training will be part of the Chemotherapy Course, which is mandatory for all such staff. For other staff groups this will be organised by the appropriate line managers. This training will be documented and traceable, but will not necessarily be subject to planned or documented review unless there are significant changes in training requirements. 2. Trial-specific training this will depend on the staff group. For example: Nursing staff in this category will be made aware that the patient is on a clinical trial and will be informed as to whom to contact regarding that trial in the event of any concerns/aes. The mode of this communication will be dependent on the activity, e.g. for IMP administration this information will be on the chemotherapy prescription. Pharmacy staff in this category will undertake trial-specific training in relation to the locally approved dispensing procedures. This training will be carried out by a member of the lead pharmacy contacts team or another member of the pharmacy team, using a cascade system. This training will be documented on a training log that is stored in the pharmacy site file for the project. Level 2-only staff will not be required to sign a delegation log, but their signature next to the activity (e.g. on the chemotherapy prescription) will constitute such signature and will be filed in the source documentation but not the Investigator Site File (ISF). Level 3: 1. GCP training full GCP training must be undertaken by this group. This will be certificated, traceable and subject to renewal in accordance with an agreed renewal schedule (currently every 2 years). Please refer to the NHS Greater Glasgow and Clyde policy on GCP. 2. Trial-specific training The Principal Investigator (PI) is ultimately responsible for the training of this group in all delegated activities within the trial. Trial-specific training logs should be maintained in the ISF and all individuals undertaking these activities will be delegated to do so by the PI and this will be recorded in the delegation log in the ISF. 3. Any member of staff who prescribes IMPs must undergo full GCP training and be listed on delegation logs. There may be some exceptions to the activities which would typically be carried out under Level 3 training, whereby certain activities may be carried out by staff who have Level 2 training only, for example, non-medical prescribing. However, this practice will only be permitted on a case by case basis, following a risk assessment by the trial Sponsor and subsequent agreement between the R&D Governance Department and the trial Sponsor. 5. CTEC REVIEW and RISK ASSESSEMENT When a trial is reviewed by CTEC, the committee will identify the level of research resource to be provided for each trial. In some circumstances (e.g. clinical trials operating within the Clinical Research Unit), all trial activity will be conducted by individuals who are fully training in the protocol and GCP (e.g. Research nurses, doctors and lead pharmacy contacts). In such cases, it may be irrelevant what levels of activity are to be undertaken. When this is not the case, the CTEC Chair will conduct a risk assessment to identify any duties that fall within Level 2 (as documented in Section 3, above). Page 2 of 5 Version 2: 08 Oct 2015
6. RETENTION OF THE POLICY DOCUMENT This policy is accessed via the public area of the CRUK CTU website. Document control, distribution and retention are managed by the CRUK CTU Quality Assurance Manager, who is responsible for ensuring that the correct version is always available, the document is reviewed appropriately and timeously, and that superseded versions are archived appropriately. 7. REFERENCES NHS Greater Glasgow and Clyde Good Clinical Practice Policy 8. DOCUMENT HISTORY Version Approved Effective Reviewed Comments Version 1 11 Jan 2013 11 Jan 2013 22 Jul 2015 Additions to text in Sections 1 and 4. Addition of Section 6 Retention of the document. Version 2 Version 3 (Revision author: Michaela Rodger) Page 3 of 5 Version 2: 08 Oct 2015
Appendix I How do I know my patient is in a clinical study? The patient s case records will have a white sticker CLINICAL TRIAL PATIENT Please check inside notes for any instructions pertaining to the study CTU Contact for Study: CTC: Ext: Study No: Why do I need to know? For patient safety The Research Team for each study is responsible for the conduct of the study in this hospital. This includes reporting patient events which may be linked to their study participation to regulatory authorities. Please note All clinicians must report any Serious Adverse Events to the CTU immediately and fully document the event in case notes The Patient Information Sheet (PIS) and consent form will be filed in the case records along with the orange registration/randomisation sheet The Chemocare prescription identifies o the Beatson Study Number o which treatments are Investigational Medicinal Product (IMP) o the Research Team contact details What do I need to report? The Research Team need to know Any hospital admissions Any change to the patient treatment schedule Any abnormal observation parameters Any treatment compliance concerns Document in the case records and contact the Research Team Who should I ask? Every study has a Principal Investigator and a Clinical Trial Coordinator. Where possible there is also a Research Nurse assigned to the study. A general query? Contact the Clinical Trial Coordinator (CTC) A treatment related query? Contact the treatment prescribing medic or clinical trial pharmacist A concern about the study? The Principal Investigator, the local clinician responsible for the study Page 4 of 5 Version 2: 08 Oct 2015
Appendix II Examples of duties categorised as levels 1, 2 and 3 Level Duties Staff Group 1 Blood pressure Nursing 1 Pulse Nursing 1 Temperature Nursing 1 Respirations Nursing 1 Pulse Oximetry Nursing 1 Height Nursing 1 Weight Nursing 1 Urinalysis Nursing 1 Urine pregnancy test Nursing 1 ECG recording Nursing 1 Blood glucometer recording Nursing 1 Phlebotomy Nursing 1 Cannulation Nursing 1 Administration of IV drugs which are non IMP (NIMP) Nursing 1 Administration of IV chemotherapy which are NIMP Nursing 1 Administration of subcutaneous and intramuscular drugs which are NIMP Nursing 1 Administration or oral drugs which are NIMP Nursing 1 Administration of oral chemotherapy which are NIMP Nursing 2 Administration of trial drugs which are IMP Nursing 2 Receipt of IMP Pharmacy 2 Environmental Temperature Monitoring Pharmacy 2 Dispensing of NIMP Pharmacy 2 Dispensing of IMP for Phase II-IV trials Pharmacy 2 Accountability of IMP Pharmacy 2 Reconciliation of IMP Pharmacy 2 Destruction of IMP with sponsor approval Pharmacy 3 Any trial activity not covered by levels 1 and 2 Page 5 of 5 Version 2: 08 Oct 2015