Where is the site sponsor located

Where the legal representative is also a co-sponsor, this should be separately recorded on the application form and details given of the allocation of sponsorship responsibilities. Evidence of insurance or indemnity cover should be provided.

For the purposes of placing a device on the Northern Ireland market, where a manufacturer is based outside Northern Ireland, a UK Responsible Person or Authorised Representative may be required to act on their behalf. Please see MHRA guidance for specific requirements, which will depend on the location of the manufacturer and device class.

The name and address of the UK Responsible Person, where required, must be included on the device labelling where the device has been affixed with a UKCA mark. EU labelling rules will apply to devices placed on the market in NI. Therefore, non-UK manufacturers acting as sponsors of research in the UK would still need to appoint a legal representative established in the UK, even though they may have appointed a UK Responsible Person or Authorised Representative elsewhere in the UK for the purposes of the regulations.

The chief investigator is the overall lead researcher for a research project Outside the UK the term Coordinating Investigator or Investigator may be used. In addition to their responsibilities if they are members of a research team, chief investigators are responsible for the overall conduct of a research project. An individual responsible for the conduct of the research at a research site. There should be one PI for each research site.

In the case of a single-site study, the chief investigator and the PI will normally be the same person. The data controller will be the organisation responsible for the management and oversight of the data. More information on the role of data controllers and personal data in health and care research can be found in our guidance.

We are still testing the new HRA website to ensure it meets your needs. Please complete our short feedback form. The Health Research Authority website uses essential cookies. Each challenge is a realistic scenario that lets users guide service members through a permanent change of station move.

Once you have completed all five challenges, you can download a certificate. The updated eSAT course also offers experienced sponsors an opportunity to demonstrate their knowledge and earn their certificate at the very beginning of the course.

Log in to an existing account or create one using a Common Access Card. The eSAT course supplements service-specific training requirements your service may have for sponsorship, so be sure to check for those guidelines. The purpose of a sponsor's audit, which is independent of and separate from routine monitoring or quality control functions, should be to evaluate trial conduct and compliance with the protocol, SOPs, GCP, and the applicable regulatory requirements.

If noncompliance that significantly affects or has the potential to significantly affect human subject protection or reliability of trial results is discovered, the sponsor should perform a root cause analysis and implement appropriate corrective and preventive actions.

For those investigators who are collecting additional data, supplemental CRFs should also be provided that are designed to capture the additional data. Allow cookies Manage Settings. Please choose all settings. Allow cookies Save Settings. The quality management system should use a risk-based approach as described below. ADDENDUM The sponsor should base their approach to validation of such systems on a risk assessment that takes into consideration the intended use of the system and the potential of the system to affect human subject protection and reliability of trial results.

Review, that may include statistical analyses, of accumulating data from centralized monitoring can be used to: identify missing data, inconsistent data, data outliers, unexpected lack of variability and protocol deviations. Verifying, for the investigational product s : That storage times and conditions are acceptable, and that supplies are sufficient throughout the trial.

The monitor specifically should verify that: The data required by the protocol are reported accurately on the CRFs and are consistent with the source documents. Informing the investigator of any CRF entry error, omission, or illegibility. The monitor should ensure that appropriate corrections, additions, or deletions are made, dated, explained if necessary , and initialled by the investigator or by a member of the investigator's trial staff who is authorized to initial CRF changes for the investigator.

This authorization should be documented. Determining whether the investigator is maintaining the essential documents see 8. Communicating deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to the investigator and taking appropriate action designed to prevent recurrence of the detected deviations.

Reports should include the date, site, name of the monitor, and name of the investigator or other individual s contacted. Results of monitoring activities should be documented in sufficient detail to allow verification of compliance with the monitoring plan.

Reporting of centralized monitoring activities should be regular and may be independent from site visits. Purpose The purpose of a sponsor's audit, which is independent of and separate from routine monitoring or quality control functions, should be to evaluate trial conduct and compliance with the protocol, SOPs, GCP, and the applicable regulatory requirements. The sponsor should ensure that the auditors are qualified by training and experience to conduct audits properly.

The sponsor's audit plan and procedures for a trial audit should be guided by the importance of the trial to submissions to regulatory authorities, the number of subjects in the trial, the type and complexity of the trial, the level of risks to the trial subjects, and any identified problem s.

The observations and findings of the auditor s should be documented. To preserve the independence and value of the audit function, the regulatory authority ies should not routinely request the audit reports. Regulatory authority ies may seek access to an audit report on a case by case basis when evidence of serious GCP non-compliance exists, or in the course of legal proceedings.

When required by applicable law or regulation, the sponsor should provide an audit certificate. ADDENDUM If noncompliance that significantly affects or has the potential to significantly affect human subject protection or reliability of trial results is discovered, the sponsor should perform a root cause analysis and implement appropriate corrective and preventive actions. The sponsor should also ensure that the clinical trial reports in marketing applications meet the standards of the ICH Guideline for Structure and Content of Clinical Study Reports.

Placebo for constipation. Radiostereometry in the Assessment of Knee Prosthesis Study. Study of efficacy of CNP in subjects with peanut allergy. Study of JB to induce operational tolerance in living donor liver. Selective C-reactive protein apheresis in ST-elevation myocardial infarction study. Study of Isatuximab, bortezomib, lenalidomide, dexamethasone in multiple myeloma. Collection of Tissue Samples for Cancer Research.

Natural History of Familial Carcinoid Tumor. Baltimore, MD, US, Horsham, PA, US, Mattawan, MI, US,