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Joint Research Management Office

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Running a study

How do I amend or make changes to the study?

What do I need to report?

What is monitoring?

What are study audits?

What are my on-going training requirements?

Do I need to continue good clinical practice training?

If there is an incident who do I report it to?

What are EDGE and NIHR metrics?

What do I do if am worried about misconduct or whistleblowing?

 

How do I amend or make changes to the study?

Any change to a study or study document is an amendment. The nature of that change determines how is it handled and approved. The sponsor of a study will determine whether they are ‘substantial’ or ‘minor’ amendments.

BH and QMUL sponsored studies 

All BH and QMUL sponsored studies follow a standard process. All amendments should be submitted to Research.amendments@bartshealth.nhs.uk

A valid amendment submission consists of:

  • IRAS amendments form for substantial amendments (for all CTIMPs both the authorisation and D.1.1 D.2.1 are signed by the Sponsor and not the CI); or, a Notification of non-substantial or minor amendment form for minor amendments with a covering letter to the REC.
  • Covering letter to the MHRA (if applicable).
  • All amended documents with track changes.
  • Completed and signed Cost Declaration Form.
  • Plus any supporting department approvals already secured by the CI, for example, pharmacy approval.
  • Written evidence that the CI approves the amendment, for example an email.
  • Revised protocols must be signed by the CI (and the statistician for CTIMPs).

Additional documentation for substantial amendments to MHRA:

  • Proof of payment of fee. Payment guidance is available on the MHRA website. Ensure evidence of payment is included in MHRA application and sent to JRMO.
  • The MHRA application should make clear the reasons for the proposed changes to the protocol or other document (for example, investigational medicinal product dossier), and show previous and new wording in track-changes.
  • Supporting information for the proposed change, including:
    • Summaries of supporting information
    • Updated overall risk-benefit assessment, considering possible consequences for subjects already in the trial.
    • Possible consequences for the evaluation of results

Do not implement any changes without site approval. An autoreply will be sent to you to indicate the documents have been received.

External sponsored studies

For all externally sponsored studies all amendments should be submitted to Research.amedments@bartshealth.nhs.uk

A valid submission consists of:

  • Notice of Amendment form
  • REC approval letter
  • MHRA approval letter (where applicable)
  • All updated documents as listed on REC approval letter
  • Updated CTA application form (where applicable)
  • HRA classification

Do not implement any changes without site approval. An autoreply will be sent to you to indicate the documents have been received.

You may implement amendments without JRMO acknowledgment provided:

  • All old versions of the amended documentation have been filed
  • All relevant staff have access to or have received the updated versions before implementation.

Full details of the amendment process can be found on the HRA website.

What do I need to report?

You must provide an Annual Report to the REC and MHRA (see DSUR below) every 12 months from the time the study was approved, signed off by the CI. This includes delayed studies, explaining any issues. Forms can be found here.

Please send a copy of the Annual report to the JRMO for our records.

For Clinical Trials of Medicinal Products (CTIMP, ATMP and Clinical Investigations) please send the report to the GCP team before any external body.

A Development Safety Update Report (DSUR) should be completed for the MHRA. 

The report must be submitted within 60 days of the reporting period. 

For more information please contact the GCP Team.

What is monitoring?

Monitoring of study data, compliance and subject rights is integral to Quality Control (QC). The sponsor decides the level and nature of monitoring based on a risk assessment of the study. Full details and templates on Monitoring can be found here.

What are study audits? 

The purpose of an internal audit is to measure compliance, data quality and performance against regulatory requirements, and to prepare the study for any external audit. 

The JRMO will do a confidential audit of a study if it is the sponsor and site host, as required by the Research Governance Framework. 

Details on the auditing process for researchers, including roles, processes, reporting and any follow-up actions, can be found here.

Find more information about the audit process [PDF 337KB], please contact the GCP team.

What are my on-going training requirements?

All staff working within research are required to have up to date GCP training. CTIMPS must update their training every 2 years. The organisation providing your refresh course depends on the type of sponsor of your research.

All BH and QMUL sponsored CTIMPs CIs are required to attend yearly CI training and yearly meeting with the R&D operations manager in addition to their GCP training, please see Sop 34 for full details.

For any GCP training information, please contact the Research Governance and GCP managers.

If there is an incident who do I report it to?

THe BH or QMUL reporting procedures should be followed whenever an incident occurs. When reporting and incident in the BH Datix system you must ensure that it is identified as a research related incident.

Reporting serious adverse events (SAE) to the JMRO

If an adverse event occurs during a trial that is sponsored by BH or QMUL the PI should assess if it is a SAE. The SAE reporting form should be sent to the JRMO.

Reports of SAEs or Suspected Unexpected Serious Adverse Reactions (SUSARs). by fax will not be accepted as due notification unless email systems are down and prior contact has been made with a member of the GCP team.

Reporting adverse events in clinical trials

The JRMO does not require externally sponsored research to report SAE or SUSARs events to them.

For Non CTIMPs, only events which are both related and unexpected should be reported to the JRMO. The appropriate JRMO template should be used. The CI should record all other events in a case report form.

For CTIMPs all SAEs should be reported to the GCP team as soon as possible. 

The CI is responsible for the medical assessment of the event, the assessment of seriousness, relatedness and expected need.

Anticipated or likely events

If an event is anticipated or likely as a result of the study population or condition, it can be excluded from the SAE reporting process only if it is clearly identified as a likely outcome in the study protocol. If the SAE is linked to the medicine used in the trial this will be classified as a Serious Adverse Reaction.

The trial sponsor must be notified of SAEs immediately and have systems in place to ensure that they are assessed for:

  • Causality (is it a reaction to a trial medicine or not?) and
  • Expectedness (is the reaction a recognised adverse effect of the medication or is it unexpected?)

Time limits for reporting incidents

Sponsors have to make sure that SUSARs are reported promptly to both the regulatory authorities (ie the MHRA) and to the relevant ethics committee. The Regulations set time limits:

  • Fatal or life threatening SUSARs: not later than seven days after the sponsor for pharmacovigilance had information that the case fulfilled the criteria for a fatal or life threatening SUSAR, and any follow up information within a further eight days.
  • All other SUSARs: not later than 15 days after the sponsor for pharmacovigilance had information that the case fulfilled the criteria for a SUSAR.

An annual safety report on all SARs (including SUSARs) must also be sent to the regulatory authorities and relevant ethics committee.

If you require further information, please contact a member of the GCP team.

What are EDGE and NIHR metrics?

All projects requiring participants at BH must be registered on EDGE. The PI is responsible for ensuring they are registered and have a delegated and appropriate person to upload accrual data. 

Edge is the Local Portfolio Management System (LPMS) for North Thames CRN and is managed by the Clinical Informatics Research Unit at University of Southampton

For more information please contact: research.submisisons@bartshealth.nhs.uk.

What do I do if am worried about misconduct or whistleblowing?

The validity of research and other academic endeavour is based on the implicit assumption of honesty and objectivity by the research investigator and on the explicit premise that research data can be verified. Both BH and universities working in partnership must uphold this principle and endeavour to maintain public trust in the research process

JRMO policy fully documents the details process that will be followed in the case of misconduct.

If you are concerned that you have witnessed or are aware of misconduct please contact the GCP team’s governance manager.

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