ECRIN - European Clinical Research Infrastructure Network

RARE DISEASES CLINICAL TRIALS TOOLBOX (EXECUTE)

Toolkit Outline

 

Define a question Risk Assessment Trial Management Statistical analysis plan Archiving
Develop a protocol Data Management Plan Regulatory submission   Trial report
Identify a Sponsor Trial Management Plan Quality management   Dissemination
Identify a Funder   Safety reporting    
    Data Management    
    Investigational Products    
    Laboratory processes    

 

 

 

 

 

 

 

 

 

 

 

Execute

Each subsection below includes two parts. The subsection opens with an explanation of the subject and guidance on how to address it. This is followed by a list of tools that have been identified in relation to this subsection. The tools listed may not be unique to clinical trials in rare diseases, this is specified in the table to better understand the use of the tool. You can visit the different section by clicking on the buttons above or return to the full toolkit here.

 

TRIAL MANAGEMENT

Trial management is the process of ensuring that a trial is run effectively and within budget and timelines. According to ICH, the sponsor should utilize appropriately qualified individuals to supervise the overall conduct of the trial, to handle the data, to verify the data, to conduct the statistical analyses, and to prepare the trial reports. The sponsor should implement a system to manage quality throughout all stages of the trial process  

For industry-sponsored trials, the sponsor usually outsources this activity to a CRO - private Clinical Research Organizations. Although there are different types of CROs and diverse levels of specialization (distinct therapeutic areas for instance), typical CRO services include regulatory affairs, site selection and activation, recruitment support, monitoring, data management, trial logistics, pharmacovigilance, biostatistics, medical writing, and project management, among others.

For academic-sponsored trials, Trial Management is usually performed by an academic Trial Coordinating Centre.

The Trial Coordinating Centre is at the heart of the trial, regardless of whether it is a single-site or multisite trial, and is usually linked to the Sponsor's institution (Hospital or University).

The Trial Coordination Center can be referred to by a variety of names and set in many different environments. It can be:

  • An academic clinical trials unit (CTU) able to provide all the services
  • An office/desk in a clinical department in a hospital/university
  • Split over different locations and be set up as a combination of the above for example a CTU can support an academic department in one or more aspects of running a trial (data management, statistics etc).

As responsible for the project management, CROs and Trial Coordinating Centers act as Global coordinators of resources, including, but not limited to:

  • Clinical site feasibility
  • General coordination of resources
  • Preparation and maintenance of sponsor’s trial master file
  • Organisation of pathways for central laboratory/biobank with instructions for single sites
  • Elaboration of the monitoring manual
  • Central clinical research associate (CRA) training (web-based and/or on-site)
  • Online, web-based central monitoring
  • Review of monitoring reports

The sponsor may transfer any or all of the sponsor's trial-related duties and functions to a CRO/Trial Coordinating Center but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor. The CRO/TCC should implement quality assurance and quality control.

 

Tool Name

Relevance Year RD/ Paediatric specific Type
Cambridge Clinical trials Unit SOPs and Documents Cambridge Clinical Trials Units SOPs and templates on: pre-trial planning, protocol development, set-up; pharmacovigilance; data management and statistics; sample management; trial management; post-study procedures and  archiving Regular updates No Template
Global Health Trials Tools and Templates library Developed by the Global Health Trials Knowledge Hub , this library of templates includes clinical trials´ general logs and trackers, documents for finances management, patients enrolment and study, site and staff management Regular updates No Template
CTTI implementation tools CTTI-developed tools to improve the quality and efficiency of clinical trials. Tools include resources to optimize recruitment and informed consent process Regular updates No Template, guideline, recommendation
UKTMN Guide to Efficient Trial Management This guideline describes the process of managing clinical trials and gives an overview of the trial management framework, both legal and operational, providing hints, tips and references to external resources 2018 No Guideline
NCCIH Clinical Research Toolbox This toolbox contains templates, sample forms, and information materials to assist clinical investigators in the development and conduct of high-quality clinical research studies Regular updates No Toolbox
Feasibility assessment of neonatal studies and selection of investigator sites/ study centres: Points to consider PedCRIN tool: This tool lists examples of points to consider for the feasibility assessment and selection of neonatal centres 2021 Yes Recommendation
Enrolment into neonatal trials: Points to consider during protocol development PedCRIN tool: This tool provides a list of points to consider during protocol development for improving the enrolment of neonatal trials 2021 Yes Recommendation
ICF template ICF template model developed by the IMI funded Do-it project. It means to cover all the information to comply with GDPR rules 2019 No Template
ICF guidelines ICF guidelines developed by the H2020 funded i-consent project. It means to provide information for the development of informed consent on research involving humans 2021 No Guideline
Regulatory and Ethics Toolkit, ICF guidelines GA4GH and IRDiRC have developed model consent clauses for rare diseases research, in order to improve data interoperability, to meet the informational needs of participants, and to ensure proper ethical and legal use of data sources and participants’ overall protection 2021 Yes Guideline
Neonatal trials and informed consent: Points to consider PedCRIN tool: This tool provides a checklist of practical points to consider when talking to parents about the possible inclusion of a neonate into a clinical trial 2021 Yes Recommendation

REGULATORY SUBMISSION

Prior to initiating a clinical trial, researchers must obtain approval from National Competent Authorities (NCA) and ethics committees to conduct a trial. For clinical trials of an Investigational Medicinal Product (CTIMP), there are a number of steps to follow:

  1. Compliance with legislation

The first step is to confirm, for international clinical trials in Europe, whether it falls within the scope of European Legislation (Clinical trials Regulation EU No 536/2014). Although the Regulation entered into force on 16 June 2014 the timing of its application depends on the development of a fully functional EU clinical trials portal and database (CTIS-EMA clinical trial information system)

The Regulation will ensure a greater level of harmonisation of the rules for conducting clinical trials throughout the EU. It introduces an authorisation procedure based on a single submission via a single EU portal (CTIS), an assessment procedure leading to a single decision, rules on the protection of subjects and informed consent, and transparency requirements.

Until the portal is fully active, for international trials in Europe, an application to the competent authority in each member state is required.

Non-international trials (single-country) would follow national legislation with a single application to the competent authority in the participating country.

  1. Registration

Prior to submission to the National Competent Authority (NCA) each trial must be registered on the European Clinical Trials Database by obtaining a EudraCT number.  

  1. Submission to National Competent Authorities

Detailed information on how to submit the application is available on the NCAs websites.  The Heads of Medicines Agencies (HMA) is a network of the heads of the National Competent Authorities (NCA) whose website links to all European NCAs.

For multinational clinical trials within Europe, the European Voluntary Harmonisation Procedure for clinical trials (VHP) was first established in March 2009 by the Clinical Trials Facilitating and Coordination Group (CTFG).  The VHP procedure fosters simultaneous initiation of the authorisation procedure for clinical trials in more than one European Member State by submitting a single application. Information regarding the VHP procedure can be found at the HMA-CTFG website, together with other important information such as:

  • Overview of the fees charged by NCAs for submission of different types of clinical trials or amendments
  • Frequently asked questions on multinational clinical trials
  • Clinical trials safety
  1. Submission to an Ethics Committee

In addition to the NCA approval, prior to commencing any trial related activities including screening and recruitment, the trial protocol should be submitted to an ethics committee (EC) for review. Clinical trials might also need to be submitted to other interested parties (Data Protection authorities).

These committees will give their opinion on the proposed participant involvement and whether activities are ethical and safe.

In some countries, the trial´s evaluation is made by more than one ethics committee: one at the country level and another local ethics committee at the Sponsor institution and/or participating sites. Upon implementation of the Clinical trials Regulation EU No 536/2014, it is expected that only one national EC approval will be needed

Ethics Committees requirements can usually be found at the NCAs websites (see above) and/or national legislation for clinical trials.

For multinational clinical trials in Europe, the CTFG (Clinical Trials Facilitating Group) has put in place a harmonized VHP-plus procedure, that involves national ethics committees in the VHP assessment (see above), aiming to facilitate the EC approval at a national level. Upon implementation of the Clinical trials Regulation EU No 536/2014, the Voluntary Harmonization Procedure (VHP) project will be closed

 

Tool Name Relevance Year RD/ Paediatric specific Type
EMA list of national competent authorities in the EU Updated list of European national competent authorities and their contact details Regular updates No Inventory
EUREC List of European Research Ethics Committees in Europe Regular updates No Inventory
CAMPUS A search tool for regulatory requirements on clinical trials per country.  Launched in December 2015 by the European Clinical Research Infrastructure Network (ECRIN) – this is an online database including country-specific information on regulatory and ethical requirements in clinical research across Europe 2015 No Search tool
Comprehensive Inventory STARS The STARS (Strengthening Regulatory Science) project has developed an online Comprehensive Inventory that assists European academic drug developers in finding various support services provided by NCAs, public actors and private entities. The inventory lists various support services including assistance in clinical trial applications Regular updates No Inventory
REGULATION (EU) No 536/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 April 2014 on clinical trials on medicinal products for human use The latest EU regulation for clinical trials on medicinal products for human use replaces national laws and describes the rules for assessing clinical
trial applications and conducting clinical trials throughout the EU
2015 No Legislation

QUALITY MANAGEMENT

The sponsor should implement a system to manage quality throughout all stages of the trial process, in particularly on trial activities essential to ensuring human subject protection and the reliability of trial results.

Quality management is the overall process of establishing and ensuring the quality of processes, data, and documentation associated with clinical research activities.  It encompasses both quality control (QC), and quality assurance (QA) activities.

  • Quality control. The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial-related activities have been fulfilled: Periodic operational checks to verify that clinical data are generated, collected, handled, analysed, and reported according to protocol, SOPs, and GCPs.
  • Quality assurance. ICH Good Clinical Practice guideline defines quality assurance as all those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented, and recorded in compliance with Good Clinical Practice and applicable regulatory requirements.

A quality management system (QMS) provides a framework for all quality management activities, including quality control, quality assurance, quality improvement and the reporting of these activities. Key elements of the QMS are:

  1. Documented procedures developed, implemented and kept up-to-date
  2. A documentation system that allows for the retrieval of any records or documentation to show actions taken, decisions made and results. All approved documents and records are version-controlled  
  3. Defined organisational and accountability charts, roles and responsibilities
  4. Appropriate documented training of personnel to meet the defined competencies of their role, and familiarisation with GCP
  5. Documented evidence to demonstrate that computerised systems are fit for purpose (validation)
  6. Quality Control (QC) activities, (review and checking). For example, monitoring of trial sites either on-site or through centralised or remote monitoring techniques
  7. Quality Assurance (QA), including an independent audit of Quality Management Assurance (QMA) processes and studies by the QA team
  8. A risk-based approach used to determine the extent of trial monitoring activities, processes and trials to audit, and computer validation activities
  9. Continuous improvement incorporating Corrective and Preventive Actions (CAPA)

Monitoring and Audit

Many professionals working in clinical research may not appreciate or understand the roles and differences between clinical research monitoring and auditing, two distinctly different functions.

Monitoring is a quality control function where study conduct is routinely assessed on an on-going basis at every step of the trial.

Auditing, a quality assurance function, is an independent, top-down, systematic evaluation of trial processes and quality control.

Quality control: Monitoring of clinical sites

ICH- GCP defines monitoring as the act of overseeing the conduct of a clinical trial, that is, ensuring that the trial is conducted according to protocol, GCP, SOP and regulatory requirements. It is the responsibility of the sponsor to ensure the trial is adequately monitored.

According to GCP guidelines, “the Sponsor may choose on-site monitoring, a combination of on-site and centralized (remote) monitoring, or, where justified, centralized monitoring alone. Centralized monitoring processes provide additional monitoring capabilities that can complement or reduce the extent and/or frequency of on-site monitoring and help distinguish between reliable data and potentially unreliable data without the need for total source data verification” (ICH GCP 5.18.3). The rationale for the chosen monitoring strategy is documented in the monitoring plan.

The monitoring plan sets out monitoring strategies, the monitoring responsibilities of all parties involved, the various monitoring methods to be used, and the rationale for their use. It also describes monitoring procedures, types of visits, what is involved in the conduct of those visits, and the quantity or percentage of each type of document to be monitored. These procedures can be further defined on a protocol basis depending on the purpose, design, size, complexity, and primary outcome measures of the trial

In general, on-site monitoring is required and remote monitoring may occur at any given research site before a trial begins, while it is in progress, and after it concludes or is terminated. In many instances, study monitors may visit each site after the first one to two participants are enrolled and then schedule subsequent visits based on multivariate criteria, such as the rate of enrolment, volume of data to review, site performance, and other considerations. Study monitors conduct site visits according to the procedures described in the monitoring plan and in accordance with Good Clinical Practice (GCP) guidelines.

Regulatory authorities and changes to guideline ICH E6 (R2) recognized the potential use of a risk-based monitoring approach to improve the conduct of clinical trials of all phases

A well-implemented risk-based monitoring process facilitates efficient and cost effective trial delivery without compromising patient safety or data quality.

Documentation of all aspects of the monitoring process is achieved through monitoring reports from on-site visits, providing clear evidence of what was checked and any non-compliance, as well as, the description of associated actions/resolution. Monitoring activities conducted centrally would be required to provide similar evidence. This also enables auditors/inspectors to reconstruct how a trial was managed.

Quality assurance: audits

Audit is defined by ICH as “a systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, sponsor’s standard operating procedures (SOPs), GCP and the applicable regulatory requirement(s)”

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. Audits are considered good practice and should be part of the Sponsor´s Quality Management system. There are three general areas of concern in the audit process regardless of which entity is performing the audit: patient safety, including consent forms and ethics committees activities; data collection and records; and the pharmacy and investigational drug supply.

Inspections

The ICH defines “inspection” as “The act by a regulatory authority (ies) of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority (ies) to be related to the clinical trial and that may be located at the site of the trial, at the sponsor’s and/or contract research organization’s (CRO’s) facilities, or at other establishments deemed appropriate by the regulatory authority (ies)”.

Inspections are performed by government regulators to ensure patient safety, welfare, scientific integrity and compliance with regulations. In Europe, regulatory authorities perform regulatory inspections of trial sites or Sponsors on a regular basis. The frequency of these inspections is based on the risk associated with the trials being undertaken. They may also perform a triggered inspection after a particular event. In most cases, the regulatory authority shall inform the main contact (normally sponsor) of an inspection but these may occasionally be unannounced.

 

Tool Name Relevance Year RD/ Paediatric specific Type
ICH Good Clinical Practice E6 (R2) This document addresses the good clinical practice, an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. It aims to provide a unified standard for the ICH regions to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions 2017 No Guideline
ICH Good Clinical Practice E6 (R2) Training course This short course aims to provide the researcher with the basic principles of GCP and how these principles can be applied practically in the research setting. The course is aimed at all those involved in clinical research. 2017 No Training
EC, Risk proportionate approaches in clinical trials Recommendations of the expert group on clinical trials for the implementation of Regulation No 536/2014
(EU) No 536/2014 on clinical trials on medicinal products for human use, as per risk based quality management
2017 No Recommendation
ECRIN_Risk-Based Monitoring Toolbox Provides information on tools available for risk assessment, monitoring and study conduct, the institutions where they are used, and other relevant details such as links and user feedback 2015 No Toolbox

SAFETY REPORTING

The sponsor is responsible for the ongoing safety evaluation of the Investigational Medicinal Product(s) used in a Clinical Trial.

Sponsors should develop formal, written processes for the management of adverse events and safety reports, including the handling of both expedited reports and annual safety reporting.

Pharmacovigilance (PV) is the science relating to the detection, assessment, understanding and prevention of the adverse effects of medicines. Some academic Clinical Trial Units (CTUs) and private CROs have PV units to support Sponsors and investigators with Safety reporting, including:

  • Validation, use and maintenance of an internal pharmacovigilance database in which all the events received and managed are recorded and where activities to be performed can be planned.
  • Expedited reports

All relevant suspected, unexpected, serious, adverse reactions (SUSARs) that occur during a clinical trial must be reported to the National Competent Authorities (NCAs) and Ethics committees of participating countries. Sponsors may use the current European portal (Eudravigilance website) to submit SUSAR reports in bulk to NCAs.

  • Annual safety reports

Development Safety Update Reports (DSURs) are internationally-harmonized, safety documents (which became mandatory in European Union Member States in September 2011) covering the safety summary of medicinal products during their development or clinical trial phase. The Sponsor is responsible for submitting annual DSURs to both NCAs and ECs in the countries involved in the clinical trial. These include:

  • Validation, use and maintenance of an internal pharmacovigilance database in which all the events received and managed are recorded and where activities to be performed can be planned.
  • Periodical reconciliation of adverse events recorded in the eCRF vs the PV database
  • Pharmacovigilance training for investigators and staff involved in the trials.

Investigators are responsible for Serious Adverse Events (SAEs) reporting to the Sponsor. SAE reporting includes investigator´s causality and seriousness assessment and must be done in a timely manner according to the protocol specifications.

 

Tool Name Relevance Year RD/ Paediatric specific Type
ICH Topic E2A: Clinical Safety Data Management Notes for definitions and standards on Safety reporting for ICH topic E A 2 1995 No Guideline
ICH Topic E2F Development Safety Update Report Guidance on Safety Reporting. The
Development Safety Update Report (DSUR) proposed in this guideline is intended to be the common standard for annual clinical trial safety reporting among the ICH regions
2010 No Guideline
Safety training Swiss Clinical Trial Organisation Tools: Safety training to consolidate investigator's knowledge of patient safety and reporting issues in clinical research Regular updates No Training
Introduction to collecting and reporting adverse events This short course provides a general introduction and overview of Adverse Events and how to deal with them when they occur. This course is suitable for everyone involved in clinical research. Regular updates No Training
Safety reporting forms Swiss Clinical Trial Organisation Tools: Set of comprehensive forms for safety reporting tailored to different types of clinical research projects.   Regular updates No Template
Causality Assessment of Adverse Events in paediatric trials PedCRIN tool: A visual algorithm based on the Naranjo scale and specifically adapted for the paediatric population to help researchers in their assessment of causality of adverse events occurring during a clinical study 2021 Yes Recommendation
Safety data analyses of neonatal trials: Points to consider PedCRIN tool: This tool provides practical points to consider when planning for the analysis of neonatal safety data 2021 Yes Recommendation

DATA MANAGEMENT

A process that begins with conception and design of the clinical trial, continues through data capture and analysis to publication, data archiving and data sharing with the broader scientific community. The Data Management Plan describes the procedures for collection and management of data throughout the lifecycle of a clinical trial.

Tool Name Relevance Year RD/ Paediatric specific Type
Research Data Management A guide to managing outputs of research projects and handling issues such as copyright and data protection laws Regular updates No Guideline
Research Data Management Kit This is a web-based resource for research data management. It has been designed to guide life scientists in their efforts to better manage their research data following the FAIR Principles as well as help researchers be more productive for themselves and their collaborators. 2021 No Toolbox
Data Certification Standards/Data Certified Units The ECRIN Data Centre Certification programme identifies non-commercial clinical trials units (CTUs) in Europe that have demonstrated they can provide safe, secure, compliant and efficient management of clinical research data 2018 No Recommendation
EDCTP Data Management portal An initiative of the Global Health Network. This tool helps to identify the areas to consider when developing a Data Management Plan, with a particular focus on data management systems and how to organise and structure data. Includes best practices for data capture, entry, processing and monitoring and how to prepare your data for analysis, sharing and archiving. Regular updates No Toolbox
EDCTP Data Sharing Toolkit An initiative of the Global Health Network,  this Data Sharing Toolkit, collates practical information and resources related to data sharing, including data management basics, data sharing steps and a repository finder Regular updates No Toolbox
Sharing and reuse of individual participant data from clinical trials: principles and recommendations (Ohmann et al., 2017) This article lists recommendations on providing access to individual participant data from clinical trials, using a broad interdisciplinary approach 2017 No Article
Evaluation of repositories for sharing individual-participant data from clinical studies (Banzi et al., 2019) This article analyses the current landscape of data repositories to create a detailed description of available repositories and assess their suitability for hosting data from clinical studies, from the perspective of the clinical researcher 2019 No Article

INVESTIGATIONAL PRODUCT/SUPPLY MANAGEMENT

An investigational product (IP), as defined by the ICH is a pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use.

Investigational Medicinal Product (IMP): Regulation (EU) No 536/2014 Article 2 (5) defines an IMP as “a medicinal product which is being tested or used as a reference, including as a placebo, in a clinical trial”.

 To ensure all regulatory and governance requirements are met, it is essential that investigators obtain advice and support from those with specialist knowledge relating to the IMP supplies (Clinical Trial Pharmacists, Clinical Trials Unit (CTU) or Contract Research Organisation (CRO)). These specialists are key to plan and advise on IMP handling. In Europe, IMP handling requires a thorough knowledge of ICH GCP sections on Supply and handling IMPs and Eudralex volumes on Good Manufacturing Practice (GMP).

It is highly recommended to start considering IMP handling from the planning stage of the trial, clearly identify the nature of the IMP and make a thorough consideration of the IMP sourcing strategy. The complexity of the process varies greatly from IMPs sourced internally and dispensed according to routine practice, to externally sourced IMPs not marketed. The IMP requirements relating to unlicensed drugs also apply to compounds that are already marketed, for example when an IMP is used for a new indication outside those for which the drug was licensed, such as for a different group of patients or for a different disease. This is especially relevant for the rare diseases clinical research, where a good number of investigator-initiated trials aim to generate knowledge on drug repurposing.

Tool Name Relevance Year RD/ Paediatric specific Type
EudraLex - Volume 10 - Clinical trials guidelines_Chapter III_Quality of the investigational medicinal product. Volume 10 of the publication "The rules governing medicinal products in the European Union" contains guidance documents applying to clinical trials. Regular updates No Guideline
EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use Good manufacturing practice (GMP) describes the minimum standard that a medicines manufacturer must meet in their production processes. The European Medicines Agency (EMA) coordinates inspections to verify compliance with these standards and plays a key role in harmonising GMP activities at European Union (EU) level. The Annex also includes guidance on ordering, shipping, and returning clinical supplies, which are at the interface with, and complementary to, guidelines on Good Clinical Practice. 2010 No Guideline
Clinical trials toolkit: Trial Supply Guide prepared by MODEPHARMA to codify good practice on drug management  in publicly funded clinical trials 2018 No Toolbox

LABORATORY PROCESSES

The analysis of samples collected from subjects participating in clinical trials forms a key part of the clinical trials process. Sample analysis or evaluation provides important data on a range of endpoints which is used, for example, to assess the pharmacokinetic profile of investigational medicinal products and to monitor their safety and efficacy. Consequently, it is essential that sample analysis or evaluation is performed to an acceptable standard which will ensure patient safety is not compromised and that data is reliable and accurately reported.

It is good practice to have well documented standard operating procedures (SOPs) that define how to conduct each laboratory procedure, whether at the clinic or laboratory (analytical) level from the sampling to the analysis and further storage or destruction, as applicable.

These apply to:

  • samples collected and analysed as part of routine clinical care, that may also contribute to the study dataset.
  • samples collected and analysed for study objectives only.
  • samples prepared and stored before shipping to a specialist laboratory.
  • samples analysed using a standard clinical assay in laboratory with a functional, audited quality system.
  • samples analysed using an exploratory/experimental assay.
  • samples collected for biobanking
Tool Name Relevance Year RD/ Paediatric specific Type
Collection, storage and use of biological samples and related data in paediatric trials PedCRIN tool: A checklist developed to help researchers, sponsors, and other affiliated personnel verify that all key aspects required to properly manage samples and related data in the context of paediatric trials are taken into consideration 2021 Yes Checklist
Reflection paper on laboratory processes for clinical trials The purpose of this reflection paper is to provide laboratories that perform the analysis or evaluation of human samples collected as part of a clinical trial, with information that will help them develop and maintain quality systems which will comply with relevant European Union Directives, national regulations and associated guidance documents. It will also provide information on the expectations of the inspectors who may be assigned by national monitoring authorities to inspect facilities that perform work in support of human clinical trials 2010 No Reflection paper
GCLP (Good clinical laboratory practice) Guidance This guidance identifies systems required and procedures to be followed within an organization conducting analysis of samples from clinical trials in compliance with the requirements of Good Clinical Practice (GCP). It thus provides sponsors, laboratory management, project managers, clinical research associates (CRAs) and quality assurance personnel with the framework for a quality system in analysis of clinical trial samples, ensuring GCP compliance overall of processes and results. 2009 No Guideline
GCP Lab guidance MHRA Guidance on the maintenance of regulatory compliance in laboratories that perform the analysis or evaluation of clinical trial samples 2009 No Guideline
Good clinical laboratory practice training Good Clinical Laboratory Practice (GCLP) guidelines describe the application of those Good Laboratory Practice principles that are relevant to the analyses of samples from clinical trials while ensuring the purpose and objectives of the Good Clinical Practice principles are maintained. Regular updates No Training