A Briefing Document contains the applicant’s questions and positions, and an overview of the available data and information. It is the most critical document of the briefing package submitted to the authority as it is the primary base of answers and recommendations by the authority.
Clinical Trial Directive
Refers to Directive 2001/20/EC which provides the approximation of the laws, regulations and administrative provisions of the European Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.
Clinical Trial Ordinance
Refers to the Swiss regulation “Ordinance on Clinical Trials in Human Research” (810.305) defining the requirements for the conduct of clinical trials in Switzerland.
Corrective and Preventive actions (CAPA)
The use of corrective and preventive action (CAPA) identifies and resolves issues within an organisation. Usually, a series of actions will be taken to resolve the problems.
Contract research organisation (CRO), a company that provides support to the pharmaceutical, biotechnology, and medical device industries for preclinical or clinical research services outsourced on a contract basis.
A Data Representative acts as your point of contact whom the EU or relevant GDPR supervisory authorities can contact for any issue related to your data processing. A data representative is mandatory for non-EU companies operating in the EU Article 27 (pg 48).
EU Clinical Trials Regulation
Refers to Regulation 536/2014 Art. 74 which provides the procedures for assessment and supervision of clinical trials throughout the EU.
European Economic Area (EEA)
The EEA includes the 27 EU countries and also Iceland, Liechtenstein and Norway.
European Medicines Agency (EMA)
European Medicines Agency (EMA) is the agency of the European Union (EU) in charge of the evaluation and supervision of medicinal products.
General Data Protection Regulation (GDPR)
The GDPR is a European regulation (EU 2016/679) on the protection of natural persons with regard to the processing of personal data and on the free movement of such data.
The goal of governance is to create a partnership where sponsors and CROs strive to share responsibility in clinical development. Milestones and KPIs are shared on a regular basis, ensuring there is consistent communication with each vendor.
Is the international guideline established by the International Council of Harmonisation (ICH) on Good Clinical Practice (GCP) describing the responsibilities and expectations of all participants in the conduct of clinical trials, including investigators, monitors, sponsors and IRBs. GCP covers aspects of monitoring, reporting and archiving of clinical trials, and incorporates addenda on the Essential Documents and on the Investigator’s Brochure.
This regulation defines the requirements of clinical investigation of medical devices. It provides guidance on how to implement Good Clinical Practice (GCP).
Key Performance Indicators (KPIs)
A Key Performance Indicator is a measurable value that demonstrates how effectively a company/project is achieving key business objectives. Organisations use KPIs at multiple levels to evaluate their success at reaching targets.
Refers to EU Clinical Trial Directive 2001/20/EC Art. 19 (pg 17). A legal representative acts as the agent of a sponsor in the event that legal proceedings are initiated and instituted within the EU/EEA. Sponsors that are established outside the EU require a legal representative in the EU.
This regulation provides pre- and post-market guidance for professionals performing clinical investigations of Medical Devices within the European Union. The regulation is designed to protect the health of patients and users and to define the standards of quality and safety for medical devices.
Orphan Designation is a status assigned by EMA to a medicine intended for use against a rare condition. The medicine must fulfil certain criteria for designation as an orphan medicine so that the drug developer can benefit from incentives such as protection from competition once the medicine is on the market.
Oversight management ensures a project is completed according to plan e.g. within budget and timeframe, ideally using tools for performance measurement like KPIs.
Quality management is a system to manage all activities and tasks needed to maintain the desired level of excellence. The sponsor should implement a system to manage quality throughout all stages of the trial process.
Request for proposal (RFP)
A request for proposal is a document used to gather proposals from different contractors or service providers. Sponsors looking to outsource their clinical activities to a CRO need to create an RFP to navigate the CRO selection process. The RFP will define the specific project requirements and once completed will determine if the CROs in question have the capability to meet the sponsor’s expectations.
Scientific Advice is the provision of advice by a regulatory authority, for example the European Medicines Agency on the appropriate tests and studies required in the development of a medicine or on the quality of a medicine.
Small and Medium-Sized Enterprise (SME)
Small and medium-sized enterprises (SMEs) are defined in the EU recommendation 2003/361. The main factors determining whether an enterprise is an SME are: staff headcount; either turnover or balance sheet total and Company category.
As a result of Brexit, the UK is no longer part of the EU and hence the GDPR no longer applies in the UK. In order to still protect the natural persons personal data, the UK implemented the Data Protection Act 2018 (DPA 2018), which is the UK’s implementation of GDPR.