Clinical Trials Support Network

NHS & Academic Clinical & Healthcare Research based in Exeter & Cornwall

CRF CTU

DIRECTOR

DEPUTY DIRECTOR

ANALYST PROGRAMMER

QUALITY & CONTRACTS MANAGER

JUNIOR PROGRAMMER

CTSN MANAGERVARIOUSCRF STAFF

Staff with CTU remit supported by core/infrastructure funding

RESEARCH FELLOW - PE

50%

50%20%100%

100%

Main purpose of the job: The Quality & Contracts Manager will provide direct support to the CTU Director and CRF Manager/Deputy CTU Director in ensuring that the CTU and CRF are run efficiently. They will play a leading role in ensuring governance compliance and financial sustainability by overseeing quality systems and contracts to recharge for CTU services.

Quality Assurance and Contracts Manager: Exeter CRF /Exeter CTU

IT Analyst Programmer

(Tim)

Quality, Contracts &

Finance Manager TBR

CTU Deputy Director/CRF Manager (Gill)

CTU Director (Rod)

Proj. Mans (e.g. MH, CA, CB)

Stats / Methods

Staff

Proj. Man.

Stats / Methods

Staff TBR

Admin &

QA

Admin &

QA(TBR)

Data Programmers and enterers

Data Man (Anita)

Data Programmers and enterers

(TBR)

CORE CTU STAFF who can be recharged to

grants/NIHR infrastructure

GRANT FUNDED STAFF officially line-managed by PI with training and CPD

supported by CTU

Definition of being part of the CTU1. The study you are working on has a “CTU number”2. The study is run to a set of quality standards agreed by the

CTU Director for the aspect of the trial attributed as being supported by the CTU

3. Staff can be managed by CTU or PI4. Completely flexible system for determining what is done by

CTU/others see: http://alf.exeter.ac.uk/share/s/po1jClwDQfWTs1GGDuutdA

Virtual Network

COMPETANCIES

https://ctsn.exeter.ac.uk/content/sop-repository

Please state which member(s) of the Clinical Trials Unit is responsible for writing and reviewing your Clinical Trials Unit’s SOPs

What we said:We have now consolidated our trial management experience into a central CTU at Exeter and have rebranded and updated SOPs. Historically, clinical trials involving experimental medicine have been run through the NIHR Exeter CRF, whilst Health Services Research Trials have been run by Institute of Health Research teams. Therefore in the past, trial staff were working to various SOPs. However, these SOPs are now managed through a central open-access document management system so that they can be read and updated from both NHS and University campuses. The CRF currently employs a part-time SOP manager, and quality management is shared between trials managers within the Institute of Health Research. As part of our CTU development, we aim to consolidate the role of SOP, quality and contract management in a single position that is currently being created.

SOPs are written by the member of the team with the greatest experience and understanding of the process to be undertaken and proof-read by a member of the team who is likely to need to follow the procedure. Once a consensus has been agreed by these staff members, the SOP is signed off by the CTU Director or the CTU Deputy Director/ CRF Manager. SOPs are given a suffix of GEN if they are applicable to both CTU and CRF. SOPs that are specific to only one study are given a study-specific suffix and signed off by the CI/PI of that study. The SOP manager (this role will be integrated into a Quality and Contracts Manager position which is currently being created) is responsible for providing SOP numbers and reminding staff of review dates. The CTU/CRF Analyst Programmer is responsible for ensuring that staff have the appropriate access to the Quality Management System in order to update SOPs.

What this means for you:• You should make yourself familiar with the generic SOPs (NIHRexe/###/GEN)

https://ctsn.exeter.ac.uk/content/sop-repository• The core CTU/CRF team will oversee core SOPS, but would like support from you

as experts in particular areas when SOPs need writing or updating.• You can use our the Alfresco portal for sharing study-specific SOPs too.

Please explain how staff are trained in implementing SOPs in your CTU?

What we said:It is the responsibility of line managers and PIs, with assistance from the Quality and Contracts Manager, to identify which SOPs should be read by their staff. It is the responsibility of staff with a Quality Management role (including team leaders, project managers and coordinators) to send web-links to SOPs within the quality management system.

All staff have access to a list of SOPs available in the document management system. This will provide a read receipt to prove that the SOP has been received. This process will be overseen by the Quality and Contracts Manager. It is the responsibility of all staff members to maintain their own training record and update central CV and training logs. It is the responsibility of Quality Management staff to monitor these training logs and to remind staff of their obligation to keep up-to-date and accurate records of this training. The Quality and Contracts Manager will undertake regular audits of this training compliance. SOPs provide written guidance, but in most cases, it is expected that this will be in addition to 1:1 training provided as part of staff induction and continuing professional development. There is significant experience within the unit in use of the SOPs and these staff will provide assistance and mentorship as required.These training logs and to remind staff of their obligation to keep up-to-date and accurate records of this training. The Quality and Contracts Manager will undertake regular audits of this training compliance. SOPs provide written guidance, but in most cases, it is expected that this will be in addition to 1:1 training provided as part of staff induction and continuing professional development. There is significant experience within the unit in use of the SOPs and these staff will provide assistance and mentorship as required.

What this means for you:• Short-term: Please read the SOPs relevant to your work and keep a record of

this.• Long-term: The Quality & Contracts Manager will manage an auditable system

to prove that we all have the relevant training for our roles in studies on the CTU/CRF portfolio.

Please explain how adherence to SOPs is monitored in your Clinical Trials Unit.What we said:In each discipline within ExeCTU/ NIHR Exeter CRF, line managers run “reliability and consistency” training sessions to ensure that different staff undertaking the same procedures are obtaining the same results and working to the same standards. As part of the annual appraisal process, staff are observed following SOPs. This process highlights whether individual staff members are performing well and also whether SOPs are still relevant and achievable in practice. At the beginning of each trial, a “delegation of roles” template will be completed. This will identify the level of trial monitoring required and who will conduct this monitoring. In many cases, the monitoring will be conducted by both CTU/CRF and sponsor staff. Where internal or external monitors identify errors in adherence to protocols, CAPA forms are completed to ensure that standards are continually improved. The Quality and Contracts Manager will be copied into all monitoring reports, and will audit studies where concerns have been raised and all studies where any GCP breeches have been reported.

What this means for you:• You should know from your delegation of roles template or trial agreement

whose SOPs you are meant to be following (e.g Sponsor, CTU) and ensure that you follow them.

• When following generic SOPs you should communicate regularly with others undertaking the same procedures to ensure consistency. The CTSN can run workshops if required.

• You should know how to report breaches of protocol/SOP and to take Corrective and Preventative action.

Ensuring data quality, please summarise your systems for:a. Monitoring receipt of data from participating sites, edit checks of data, generation of queries and

receipt of response to those queries. Include information about procedures for ensuring retention of original and updated data.

What we said:The level of monitoring required for each trial is assessed following a risk assessment by the CTU (see SOP NIHR/196/GEN) and the sponsor, and this level of monitoring is specified within the delegation of duties template (see SOP NIHRexe/191/GEN). The principles of these levels of monitoring are provided in SOP NIHRexe/197/GEN. The CTU currently supports a number of models of data collection, including first electronic entry by site staff (see SOP NIHRexe/153/GEN), teleform scanning of original data, followed by data checking by CTU staff and direct collection of electronic data. Where paper data collection forms (DCF)s are used, data is entered onto the study database by the recruiting site’s research staff within 1 week of a participant’s visit. DCFs are scanned and sent to the lead site/CTU within 2 weeks of a visit. DCFs and first data entry are checked by CTU staff and queries are logged on a Data Query Form (DQF) and sent to the site’s research team for the recruiting nurse to check and resolve. Queries are expected to be resolved within 2 weeks of being raised. Corrections are signed and dated on paper DCFs, re-scanned and sent back to the lead site/CTU (original copies are filed with TMF). The Data Query Log and database entries are updated within 1 week of queries being resolved. Queries may also be raised following interim data analysis that alerts the lead site/CTU staff to anomalies/ outliers/ samples. Data is cleaned by CTU staff; methods used will be dependent on the model used for data entry (see SOP NIHRexe/202/GEN). Source data (usually in the form of data collection forms) are kept in their original format until data cleaning is complete. As part of Trial Closure (NIHE/exe/187/GEN) and archiving procedures, paper DCFs are scanned and pdf files are stored on a secure database. Paper DCFs are then destroyed following confidential paper waste procedures. Electronic data is archived and held securely, as detailed in SOP NIHRexe/209/GEN.

What this means for you:• Where a study has agreed that the CTU will take responsibility for monitoring you must

follow the Generic SOPs.

b. Ensuring patient confidentialityWhat we said:All identifiable patient data stored within CTU or CRF management systems is protected via permission based logins which require a username and secure password to prevent unauthorised access. These logins are time-limited before logging the user out, and enable areas of sensitive data to require additional permissions before access. The systems also ensure logging in and accessing the data only takes place over a secure connection and that all activity is audited. In addition to the inherent protection provided by the IT systems, it is mandated SOPs covering storage, transfer and processing of data written in line with Good Clinical Practice guidelines and the Data Protection Act legislation must be followed.

What this means for you:• All staff handling data under the auspices of the CTU should be trained in

Data Protection and follow relevant SOPs.

c. Adverse event reportingWhat we said:In the case of SAEs/SARs/SUSARs, the CI/PI will be expected to report the incident to the sponsor in a timely manner, as described in the SOP. A risk assessment will be conducted prior to starting the research project and safety report procedures defined, either following the pharmacovigilance and safety monitoring SOP or the sponsor’s SOP. The QA/CTU Manager will develop and maintain a database of all Serious Adverse Events (SAEs), Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) in clinical trials within the ExeCTU portfolio.

The QA/CTU Manager will oversee the day to day management of the CTU pharmacovigilance system for the reporting and recording of SAEs and for the expedited reporting of SUSARs to the Medicines and Healthcare Products Regulatory Agency (MHRA) and Research Ethics Committees (RECs). Their role will also include developing systems to assist CIs with the production of annual safety reports to the MHRA and RECs, and providing on-going advice to the clinical teams regarding the collection of data and reports for data committees and sponsors.

What this means for you:• Long-term: the Quality & Contracts Manager will ask you to copy them in on

all AEs.

4.7 Please explain who undertakes risk assessment for your clinical trial and explain how this guides monitoring of the whole study process including central committees such as Trial Steering Committees, Data Monitoring Committees.What we said:All studies adopted onto the CTU or CRF portfolio will have a risk assessment undertaken following SOP NIHRexe/196/CRF. This produces a risk score. The sponsor may also undertake their own risk assessment. Prior to ethical approval, CIs are expected to complete a study delegation template NIHRexe/191/GEN. In this document, they will specify who will conduct monitoring and to what level, and who will coordinate DMCs and TSCs. The sponsor has the right to refuse sponsorship if they feel that the provision for monitoring and trial management is not sufficiently robust and may insist that the CTU specifically provides these services.

What this means for you:We have templates that core staff can help you to complete.

The wonders of the Alfresco system: How it will make continually meeting these standards in an auditable manner simple and easy:

Levels of Access

“For Information only” - https://ctsn.exeter.ac.uk/content/sop-repository

“Read-receipt read only” – no login in to Alfresco needed, but provides audit trail.

“Login to Alfresco” – to send SOPs to others /add content to Alfresco