2012

February 2012

Tissue Governance Arrangements within Tayside (17/02/2012)

Following the publication of the recent Chief Medical Officer letter “Accreditation Scheme for the Collection and Storage of NHS tissue in Scotland” (SGHD/CMO (2011)7) there is a requirement for governance and specimen tracking to be in place for all research conducted using patient samples. Please click on the pdf link below for further details.

 Tissue Governance Arrangements within Tayside

Delegation of Significant Trial-related Activities   (20/2/12)

The Medicines for Human Use (Clinical Trials) Regulations outline the role of the investigator undertaking a Clinical Trial of Investigational Medicinal Products (CTIMPs). 

The investigator should maintain a list of appropriately qualified persons to whom the investigator has delegated significant trial-related duties.

The Chief/Principle Investigator must ensure that a delegation of responsibilities log is held and maintained and that all staff named on the log are qualified by education, training and experience. Staff undertaking a significant trial related activity, for example screening participants, obtaining informed consent or CRF completion, must be recorded within this log.

For clinical research not involving Investigational Medicinal Products it is strongly recommended that a delegation of responsibilities is put in place.

TASC SOP23, found on the TASC website, provides a template delegation of responsibilities log.

Source Document Requirements and Clinical Trial Inserts (20/2/12)

The Medicines for Human Use (Clinical Trials) Regulations 2004 states that all clinical trial information shall be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification.

Source documents and other trial records should be accurate, complete and kept up to date throughout the study.  Source documents are considered to be all original documents, data and records pertaining to the study such as medical notes, blood results, patient diaries, pharmacy records, etc.

Clinical Trial Inserts

NHS Tayside Medical Records Department have provided TASC with Clinical Trial (CT) Inserts for use by clinical research staff who use patient case notes as part of their study process. A CT Insert should be placed towards the front of a case note when a patient consents to take part in a clinical trial.

Trial-associated documents e.g. original signed informed consent form, study contact(s) information, participant information sheet, inclusion/exclusion criteria form, screening form, randomisation form, study prompt sheets, and any other appropriate source data, should be filed behind the CT Insert.

CT Inserts are held in the TASC Office (Monitors Room) and in CRC. Monitors will also make them available to researchers at monitoring visits. In addition, the Medical Records Office will hold a small supply of Inserts for occasions when research staff cannot access them from TASC or CRC.

A separate Hot Tip that provides archiving information for trial documentation and can be found on the TASC website at Hot Tip on Archiving.

Suspension or Early Termination of a Trial (20/2/12)

The trial protocol must include a definition for the end of a trial for which TASC recommends the last visit of the last trial participant, although this could be different depending on the trial design. According to The Medicines for Human Use (Clinical Trials) Regulations 2004, the Sponsor must notify the relevant competent authority within 15 days of termination or suspension with a clear explanation of the reasons for termination.

The information should be notified to the competent authority using the End of Trial Form and should include the following information:

• Name and address of the Sponsor’s (or sponsoring group’s) legal representative in the Member State
• Title of the trial
• EudraCT number
• Trial protocol code number
• Date of end of trial
• Date of end of complete trial in all participating centres in all countries within and outside the EU, when available
• Brief explanation of the reasons for early termination or suspension.

A Clinical Trial Report must also be submitted to the authority within 12 months of termination or suspension and should include:

• Justification of the premature ending of the trial
• Number of patients still receiving treatment at time of study termination
• Proposed management of patients receiving treatment at time of study termination
• Consequences for the evaluation of results.

Responsibility for notifying the Authority of early termination or suspension lies with the CI or delegate. The End of Trial Form can be found at: http://ec.europa.eu/health/files/eudralex/vol-10/declaration_end_trial_form.pdf

In instances where you are considering termination or suspension of a trial, please contact your TASC Trial Monitor who will be able to advise you on the procedure for notification.

Washout Period for Participants between Trials (20/2/12)

During the MHRA GCP Inspection in Tayside in March 2011, the inspectors noted that some trial subjects had participated in more than one drug trial at the same time. In order to prevent carryover effects and potential IMP interactions, the EMA guidelines state that there must be an appropriate washout period between a participant completing one trial and being included in another. However, the guidelines do not provide a standard duration for the washout period since this is dependent on the characteristics of the IMPs concerned.

TASC recommends that a washout period of at least 30 days should elapse from the end of the participant’s involvement in a trial before being considered for enrolment in a new trial. This standard washout period is included in the TASC Protocol Template for researchers and should not be removed or the period shortened without the agreement of TASC. Researchers should also consider whether the washout period may need to be longer than 30 days, for example where it is known that the IMP in the first trial has a long half-life.

March 2012

The Health Informatics Centre (HIC),  (06/03/2012)

The Health Informatics Centre (HIC), after more than a year of pilot work and user-engagement, has now implemented the TASC remote-access Safe Haven. Across Scotland research data providers are adopting safe havens in response to changes in the UK information governance landscape. These require improved security and accountability for the use of routine clinical data.  All new projects with research teams accessing anonymised data for research analysis via HIC are now required to use the Safe Haven remote access system. This is a best-practice secure environment for the hosting, processing and analysis of data. Please click here for  pdf summarising the use of the TASC Safe Haven prepared by HIC. IF there are any queries about this PDF please contact Duncan Heather on the email above, thanks.

Kind Regards Jill Belch

 June 2012

Dear All

There are very important changes about to take place in the way clinical trial grants’ NHS costs will be calculated in the future. It is thus MOST IMPORTANT that you discuss the costs well in advance of your submission to a funding body.

As you will see from the attached a new Scotland-wide system, AcoRD, will be introduced into all new trial costings from 1st Oct to bring us in line with England. It is not easy to understand, and there are significant changes to cost allocations to various groups. TASC will be trained up in using this well before October, but it is complex, teething problems will occur, so I ask two things:

1.       Adherence to the 10 day rule for submissions for NHS costings

2.       Face to face (or tel) discussions with TASC managers will really make this easier, rather than Liz’s team costing up without discussion.

NOTE: Unlike previously the CSO will only give what is asked for, further if any cost is wrongly attributed the funding will not be issued, so there is a very real chance of loss if the TASC staff are not consulted. We will have a ‘check’ person at CSO so we must allow time for them to see the costings before sign off (sorry folks).

I know it is disheartening to see more changes to an already complex system, but the TASC Team will see you through these, and hopefully it will not be too troublesome.

Read more.........

 July 2012

Funding Applications Data request

 Please will you ensure that ALL clinical research proposals and clinical funding applications are notified to TASC generic mailbox at [email protected]  and copied to Jim Griffin  [email protected]  as early as possible and in parallel with RIS/CRSF so as to allow sufficient time for TASC R&D Costings team to review ALL associated NHS costs with the proposed research.

 This may well include "research" costs that require inclusion in the funding application itself and so it is imperative that we all work closely together to ensure appropriate attribution of costs to the correct budget.

 In order for TASC R&D to review clinical research applications we require the following documentation as and when available. Please do send the documents as soon as each becomes available. We do NOT require you to wait until all are ready and send them in together as this will delay the process:

1. proposal/protocol - details of research

2. copy of the Costing PRF - and amended & final signed version

3. copy of the funding application and associated paperwork/details

4. outline of where, when and who will be undertaking the research

5. copy of the Governance PRF - we will work with the research teams to identify and agree the NHS support components

 Please ensure that TASC R&D Costings team is notified of any significant changes to the proposal that may impact on NHS support or resources. We can only review and cost for the information provided and cannot confirm availability of NHS support arising as a result of a change in the proposal not notified, discussed and agreed with the relevant R&D office.

 We request early notification to allow appropriate review and follow up with the applicants and grants offices. This is particularly important for multicentre research applications.

 Thank you for your assistance in this matter.

 Kind Regards,

 Liz Coote

R&D Manager

November 2012

EXCHEQUER ACCOUNTS 15/11/2012

As some of you may know, cogent legal reasons prevent us now from transferring the surplus money from commercial trials to endowments funds.  The NHS is working hard to resolve this and we will be circulating a full summary in due course.  The reason for this interim Hot Tip is that all this has taken some time to organise and I sense that an interim email might help to reassure Investigators about forthcoming plans.

Cameron Glen and his team will prepare a paper showing the surplus you will accrue on 100% recruitment, for your information at the start of the work.

As it is now not possible to transfer surplus from commercial studies to the endowments, the plan is now to have EXCHEQUER ACCOUNTS. The commercial surplus will be calculated in TASC.  TASC will then transfer the surplus to a separate account and at the same time email you that this has happened.  This account will be clearly named with the PIs name and be ring fenced.  The rules of engagement will be similar to those of endowment funds in that up to £10K can be spent without approval but for £10K and above a small project form, such as was completed for endowments, requires to be submitted to the TASC office for approval.

An additional requirement will be for budget setting thus, if you have £10K within this new exchequer account, then you will have to draft out a rough budget such as follows e.g.:

Year 1 - £3K on computing

Year 2 - £4.5K travel to meetings

Year 3 - £2.5K towards a Research Fellow

Such budget setting allows the NHS to retain the funds rather than rolling the balance over to zero annually.   This money will be reserved for the Investigator, there is no change in this apart from the need to budget set.

Full details of these new exchequer accounts will be circulated in due course. I will be happy to discuss this with you, if required.

Kind regards

Jill Belch