Link To NIH’s ClinRegs Online Database of Country-Specific Clinical Research Regulatory Information

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ClinReg, Country-Specific, NIH, Regulatory Information, Research

https://clinregs.niaid.nih.gov/

Welcome

ClinRegs is an online database of country-specific clinical research regulatory information designed to assist in planning and implementing international clinical research. Countries are included based on NIAID’s international clinical research priorities. For additional information, see the About page. 

If a country you are looking for is not included in ClinRegs, consider the following resources:

• HHS OHRP’s International Compilation of Human Research Standards
• European Clinical Research Infrastructure Network’s CAMPUS for Regulatory and Ethical Requirements

For questions or comments, please click on Contact Us at the top of the page or take our Feedback Survey.

Check out the ClinRegs fact sheet and share it with your colleagues!

NIH Link to Clin Reg for Thailand

Tags

FDA, guidance, health, medical-device, news

Thailand Profile Updated

21Mar2024

The Thailand profile in ClinRegs has been reviewed and updated with the following information: 

• Revised requirements and documentation for importing drugs for clinical research (See the Regulatory Authority, Ethics Committee, Clinical Trial Lifecycle, Sponsorship, Informed Consent, and Investigational Products topics) 
• Revised requirements and documentation for producing drugs for clinical research (See the Regulatory Authority, Ethics Committee, Clinical Trial Lifecycle, Sponsorship, Informed Consent, and Investigational Products topics) 
• Updated Thai Food and Drug Administration (Thai FDA) E-Submission System guideline from 2023 (see Submission Process) 
• Webpage and related documents and forms providing Thai FDA drug import waiver request instructions (see Regulatory Fees and Submission Process) 
• Webpage and instructions related to requesting a License Per Invoice (LPI) via the Thai FDA (see Submission Process) 
• Webpages and forms for requesting permission to use the Thai FDA’s One Stop Service & Consultation Center (OSSC) E-Consult Service (see Submission Process)
• Central Research Ethics Committee (CREC) fees issued in 2022 and payment instructions (see Ethics Committee Fees) 
• Updated CREC project submission documentation from 2022 and 2023 (see Submission Process, Submission Content, and Documentation Requirements) 
• List of Thai FDA approved ethics committees from 2023 (see Ethics Committee and Oversight of Ethics Committees)

Certified Copies (ISF-TMF)

Tags

Certified Copies, GCP

Important issues

1. Certified Copy:– Scanning or transfers to other media

Certification of Scanned documents filed in TMF. A process or SOP should be filed, clearly indicating the certification Validation process .

According to Article 58 “the media used to archive the content of the clinical TMF shall be such that the content remains complete and legible” throughout the retention period. Particular attention should be paid when records are stored on electronic, magnetic, optical or other no-indelible media. In such cases suitable controls should be implemented to ensure that these records cannot be altered without  appropriate authorization and the creation of an audit trail.

Digitized documents in the e-TMF should be a certified copy of the original.

Validation of the digitization process 

The use of e-TMFs and electronic archiving generally requires the digitization of paper records to  generate electronic copies of the documents. When original paper TMF documents are transferred to an electronic format, the process of transfer should be validated in order to ensure that the information will  not be lost or altered. A certified copy is a paper or electronic copy of the original record that has been verified (e.g. by a dated signature) or has been generated through a validated process to produce a copy having the exact content and meaning of the original.

• 2 clear messages – but require clarity
  • Certification NOT needed if original remains in ISF (Reg Binder) or sponsor TMF
    • i.e. certification only if copy is permanently REPLACING the original (original destroyed or otherwise not available)
  • Except: certification needed if eTMF presented to Reg/ exp. MHRA as the official TMF

SOURCE DOCUMENT	COPY PROCESS	WHAT HAPPENS TO COPY?	CERTIFY?	NOTES
Original at investigational site and maintained in ISF e.g. delegation log	Photocopy made at site and brought or emailed to sponsor	Photocopy filed in paper TMF	No	Original available for validation purposes if needed
Original at investigational site and maintained in ISF e.g. delegation log	Photocopy made at site and brought or emailed to sponsor	Photocopy scanned. PDF filed in eTMF	No	Original available for validation purposes if needed
Original at investigational site and maintained in ISF e.g. delegation log	Scanned copy uploaded via Sponsor eTMF portal	PDF filed in eTMF	No	Original available for validation purposes if needed
Copy at investigational site and maintained in ISF e.g. EC constitution (original at EC)	Photocopy made at site and brought or emailed to sponsor	Photocopy filed in paper TMF or scanned and saved to eTMF	No	No need to certify a copy of a copy
Microsoft Office document at site/CRO/vendor or deleted once transmitted to sponsor	Original sent by email as attachment to sponsor (though technically, it is actually a copy)	Original Microsoft Office document as received by sponsor filed in eTMF	No	Microsoft Office document considered to be the original

SOURCE DOCUMENT	COPY PROCESS	WHAT HAPPENS TO COPY?	CERTIFY?	NOTES
Microsoft Office document e.g. Word	Printed or saved to PDF using standard out-of-the-box “save as” functionality	PDF saved in eTMF	No (although could be ‘it depends’)	‘Save to PDF’ and ‘Print to PDF’ is identical to ‘Print to printer’… which does not need certifying
Wet-ink paper original held by sponsor and maintained by sponsor	Scanned copy uploaded to TMF and checked against original	PDF filed in eTMF	Yes	Only if eTMF is primary TMF. Unclear Rationale for certification
Paper original held by sponsor and destroyed after eTMF upload e.g. SAP	Scanned copy uploaded to TMF and checked against original	PDF filed in eTMF	Yes	Scanned copy is replacing the original which is being destroyed
Paper original held by sponsor is archived after eTMF upload e.g. filenote	Scanned copy uploaded to TMF and checked against original	PDF filed in eTMF	Yes	Unclear Rationale for certification

ISO Country Codes

https://www.iso.org/obp/ui/#search

https://www.ncbi.nlm.nih.gov/books/NBK7249/

For definition of the different code types, please click here

Link To :-Guidance Regarding Methods for De-identification of Protected Health Information in Accordance with the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule

Tags

De-identification of PHI, HIPAA, PHI

https://www.hhs.gov/hipaa/for-professionals/privacy/special-topics/de-identification/index.html

This page provides guidance about methods and approaches to achieve de-identification in accordance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule. The guidance explains and answers questions regarding the two methods that can be used to satisfy the Privacy Rule’s de-identification standard: Expert Determination and Safe Harbor¹.  This guidance is intended to assist covered entities to understand what is de-identification, the general process by which de-identified information is created, and the options available for performing de-identification.

General

1.1 Protected Health Information
1.2 Covered Entities, Business Associates, and PHI
1.3 De-identification and its Rationale
1.4 The De-identification Standard
1.5 Preparation for De-identification

Guidance on Satisfying the Expert Determination Method

2.1 Have expert determinations been applied outside of the health field?
2.2 Who is an “expert?”
2.3 What is an acceptable level of identification risk for an expert determination?
2.4 How long is an expert determination valid for a given data set?
2.5 Can an expert derive multiple solutions from the same data set for a recipient?
2.6 How do experts assess the risk of identification of information?
2.7 What are the approaches by which an expert assesses the risk that health information can be identified?
2.8 What are the approaches by which an expert mitigates the risk of identification of an individual in health information?
2.9 Can an Expert determine a code derived from PHI is de-identified?
2.10 Must a covered entity use a data use agreement when sharing de-identified data to satisfy the Expert Determination Method?

Guidance on Satisfying the Safe Harbor Method

3.1 When can ZIP codes be included in de-identified information?
3.2 May parts or derivatives of any of the listed identifiers be disclosed consistent with the Safe Harbor Method?
3.3 What are examples of dates that are not permitted according to the Safe Harbor Method?
3.4 Can dates associated with test measures for a patient be reported in accordance with Safe Harbor?
3.5 What constitutes “any other unique identifying number, characteristic, or code” with respect to the Safe Harbor method of the Privacy Rule?
3.6 What is “actual knowledge” that the remaining information could be used either alone or in combination with other information to identify an individual who is a subject of the information?
3.7 If a covered entity knows of specific studies about methods to re-identify health information or use de-identified health information alone or in combination with other information to identify an individual, does this necessarily mean a covered entity has actual knowledge under the Safe Harbor method?
3.8 Must a covered entity suppress all personal names, such as physician names, from health information for it to be designated as de-identified?
3.9 Must a covered entity use a data use agreement when sharing de-identified data to satisfy the Safe Harbor Method?
3.10 Must a covered entity remove protected health information from free text fields to satisfy the Safe Harbor Method?

Reference

https://www.hhs.gov/hipaa/for-professionals/privacy/special-topics/de-identification/index.html

Link To :-Article on GUIDE TO Protected Health Information (PHI)

by Marjorie A. Bowman Rose A. Maxwell beginner’s guide to avoiding Protected Health Information (PHI) issues in
clinical research

Protecting personally identifiable information is important in clinical research. The authors, two faculty members involved in developing and implementing research
infrastructure for a medical school, observed challenges novice researchers encountered in recognizing, collecting, and managing Protected Health Information (PHI)
for clinical research. However, we had difficulty finding resources that provide practical strategies for novice clinical researchers for this topic. Common issues for
beginners were:

1. Recognition of PHI, e.g. lack of recognition of ‘indirect’ PHI, i.e., that the combination of two or more non-PHI data types or other specific
information could result in identifiable data requiring protection;

2. Collection of PHI, e.g., proposed collection of data not necessary for fulfillment of the project’s
objectives or potential inadvertent collection of PHI in free text response items; and

3. Management of PHI, e.g., proposed use of coding systems that directly included
PHI, or proposed data collection techniques, electronic data storage, or software with inadequate protections.

From these observations, the authors provide the
following in this paper:

1. A brief review of the elements of PHI, particularly ‘indirect’ PHI;

2. Sample data management plans for common project types relevant to
novice clinical researchers to ensure planning for data security;

3. Basic techniques for avoiding issues related to the collection of PHI, securing and limiting access to
collected PHI, and management of released PHI; and

4. Methods for implementing these techniques in the Research Electronic Data Capture (REDCap) system, a commonly used and readily available research data management software system

References

HIPAA Compliance for Reporters to FDA MedWatch

What Health Information Is Protected by the Privacy Rule? ( NIH)

Link To:-The Impact of ICH GCP E6 Guideline R2 Revisions on Sponsors, Sites, Contract Research Organizations and Vendors

The-Impact-of-ICH-GCP-E6-Guideline-R2-Revisions-on-Sponsors-Sites-Contract-Research-Organizations-and-Vendors/

Abstract

The ICH GCP E6 revised guideline was issued to reflect on the current research landscape: increase in globalization, studies complexity, and technological capabilities. The updated ICH GCP E6 (R2) Addendum is more descriptive than the previous version and contains 26 items of change. These changes consist of new items in definitions; new sections on investigator responsibilities, including oversight; a substantial new sponsor section on quality management, including risks assessment; monitoring plans defined and implemented; introducing risk-based quality management; serious breaches, and, a new section on computer validation and electronic records, etc. This review will explore the changes to provide a better understanding of how they impact conduct of clinical trials for sponsors, participating sites, CROs and vendors.

Link to the Templates • Global Health Trials (tghn.org)

Templates

Welcome to Global Health Trials’ tools and templates library. The templates below have been shared by other groups, and are free to use and adapt for your research studies. Please ensure that you read and adapt them carefully for your own setting, and that you reference Global Health Trials and The Global Health Network when you use them. To share your own templates and SOPs, or comment on these, please email info@globalhealthtrials.org. We look forward to hearing from you!

These templates and tools are ordered by category, so please scroll down to find what you need.

Category	Tool or Template	SOPs
General Logs and Trackers	Telephone contact log	Generic SOP template
Meeting Minutes Template	Management of SOPs SOP
Regional Meeting Budget Template with Example Data	Identifying Critical Suppliers SOP
	Preparing SOPs SOP
Developing protocol	Concept protocol – template	Risk Assessment for Trial SOP
Protocol feasibility checklist	Protocol feasibility assessment SOP
Risk assessment template	Protocol Amendments Assessment SOP
	Investigator brochure or IMP dossier development SOP
Disseminating findings	Clinical study report template
Finances Management	Budget Monitoring tool
Budget Monitoring tool with example data
Budget Tool – Cost by Category
Budget Tool – Cost by Patient
Essential Documents	Essential documents checklist	Investigator site file (Master File) set up and maintenance SOP
Trial Master File Contents List	Archival of essential documents SOP
	Archiving trial data SOP
	Investigator brochure or IMP dossier development SOP
Enrolling and retaining participants, managing visits	Enrolment log	Screening SOP
Subject identification log template	Recruiting study participants SOP
Subject screening log template	Follow up visits SOP
Subject visit log vaccine trial	Pre and post admission study team meetings SOP
Subject visit log any trial	Blood Sampling SOP
Subject withdrawal and termination log	Reimbursement of Study Subjects SOP
Pre-screening eligibility check template	Transfer of patients SOP
Screening procedures
Interviewer recruitment log
Participant communication log
Interviewer follow up form
Partitipant Retention Plan
Informed Consent and Counselling	Informed consent template – generic	Audiovisual recording of informed consent SOP
Informed consent template for clinical trials	Reviewing and obtaining informed consent SOP
Informed consent template for observational in-patient clinical trials
Informed consent template for interviewing research studies
Informed consent template sampling only
Monitoring informed consent checklist
Subject informed consent log template
AudioViual recording informed consent checklist
Opinion leader inputs – meeting records
Informed Consent Sample only in household community
Providing clinical care	Concomitant medication log	Managing biological samples SOP
	Preparation for clinical conduct SOP
	Transfer of patients SOP
Handling Biomedical Products		Blood Sampling SOP
	Managing biological samples SOP
IMP Management	Drug accountability log template	Receiving IMP SOP
Drug supplies record template	Packaging and labelling IMP SOP
Acknowledgement of IMP receipt template	Disposal of IMP SOP
Pharmacy Accountability form template	Managing IMP SOP
Packing of IMP form template
Investigator IMP accountability form
IMP return form template
Receipt for IMP destruction
IMP Temperature log
Lab selection form
Data Management	Data handling study team agreement	Data Recording SOP
Data clarification form
Data management plan
CRF template -generic malaria
CRF template generic
CRF tracking template
Data Safety Monitoring Board (DSMB) charter
Data Collection	CRF template -generic malaria	Data Recording SOP
CRF template generic	Blood Sampling SOP
CRF tracking template
Study and Site Management	Trial contacts sheet	Investigator site file (Master File) set up and maintenance SOP
Logs List Template	Communication with sponsor or contract research organisation SOP
Essential documents checklist
Trial Master File Contents List
Study Initiation	Site initiation checklist	Site initiation, activation and close out SOP
Site readiness checklist for vaccine trial
Study Close	Study Close-Out – Premature termination checklist	Site initiation, activation and close out SOP
	Archival of essential documents SOP
	Archiving trial data SOP
Site Selection	Site selection visit form	Identifying Critical Suppliers SOP
Site selection visit checklist
Site assessment and feasibility questionnaire
Site assessment questionnaire template
Site Feasibility Tracker
Site Feasibility Contact Log
Site feasibility report
Site initiation checklist
Site readiness checklist for vaccine trial
Lab selection form
Staff Management	Master training log	Communication with sponsor or contract research organisation SOP
Delegation of authority log	Study team training and study handover SOP
Study team responsibilities
Ethics and Human subjects Protection	Ethics committee application letter format	Reviewing and obtaining informed consent SOP
Ethics committee submissions checklist	Audiovisual recording of informed consent SOP
Informed consent template – generic	Risk Assessment for Trial SOP
Informed consent template for clinical trials	Emergency Scenario Training SOP
Informed consent template for observational in-patient clinical trials
Informed consent template for interviewing research studies
Informed consent template sampling only
Informed Consent Sample only in household community
Subject informed consent log template
Monitoring informed consent checklist
AudioViual recording informed consent checklist
Ethics committee approval letter template
Risk assessment template
Interactions with IEC (Institutional Ethics Committee) SOP
Risk, Safety and Adverse Events (AEs) Management	Adverse Event Record	Safety assessment and reporting SOP
Adverse Event Log Template	Risk Assessment for Trial SOP
Serious adverse events log	Non compliance to protocol SOP
SAE reporting checklist	Emergency Scenario Training SOP
Serious adverse events form template
Data Safety Monitoring Board (DSMB) charter
Agreements, approvals and contracts	Clinical trial agreement	Clinical Trial Agreement (CTA) with sponsors or contract research organisations (CROs’) SOP
Clinical trial agreement log	Interactions with IEC (Institutional Ethics Committee) SOP
Confidentiality and NDA Template
Interviewer contract English
Interviewer contract French
Data handling study team agreement
Regulatory binder table of contents
Ethics committee approval letter template
Quality Assurance	Monitoring checklist – internal	Non compliance to protocol SOP
Monitoring activities Template	Monitoring visits SOP
Monitoring agreement for local independent safety monitor template	Monitoring SOP
Monitoring informed consent checklist
Monitoring plan template
Monitoring visit log
Monitoring Curriculum
Protocol Adherence	Protocol deviation log	Non compliance to protocol SOP
Protocol training log	Protocol amendment assessment SOP
Protocol violation log

Satellite Site in Clinical Studies.

The satellite site is a study site that is linked to an existing parent site where the parent site and the satellite site share the same principal investigator. Subjects are seen by the same principal investigator and visit both the parent site and the satellite site according to their own business requirements

Managing Satellite Sites and Contacts for Clinical Trials

You manage satellite sites and contacts for clinical trials in the same way that you manage normal sites and contacts for clinical trials. For more information, see the following topics:

• Satellite sites function in a similar way to normal sites. From a business perspective, it is important to track all the satellite sites for a parent site and ensure that the protocol guidelines are being followed at the satellite as defined for the parent site. Other important issues to note before starting to create and manage satellite sites for clinical trials include the following:

• A site can have multiple satellite sites, but each satellite site can have only one parent site.
• If a subject visit happens at a site, then all corresponding activities also happen at the same site.
• All roll up and roll down of information in the standard hierarchy for the parent site (Protocol – Region – Site) applies for the satellite site. This includes the roll up and roll down of the following information: position, payment, subject status, and contract amount.6-5
• Bulk actions carried out at the protocol and region level for the parent site (such as activity, account, document tracking, and payment generation) apply for the satellite site.
• The following data is consolidated from the parent site to the satellite site: subject enrolment, accrual payment, contract amount, and payment amount.
• The satellite site and parent site can be of different types. For example, even if the parent site is a Hospital and the satellite site is a Private Clinic, the same principal investigator conducts the study for both sites.
• The satellite site inherits the parent site’s subject visit template version, principal investigator, team, and currency information by default. Any change in the subject visit template version, principal investigator, team, or currency information is rolled down from the parent site to the satellite.
• The subject enrollment of data from the satellite site is rolled up to the parent site.
• The payments and contract data from the satellite site is rolled up to the parent site.
• Monitoring  of endpoints  performed outside  the investigator  site  (e.g., central  reading facilities,  central  laboratories) should  be addressed in the monitoring  plan.” Recommend that  ICH E6 R3 also  provide  expectations  with  regards to potential  involvement  of satellite  sites  and adequate supervision  by sponsor and investigator  at multiple  sites? (e.g. IP availability / transfer  between parent and satellite  sites, maintenance  of source records, monitoring, etc)
• The following use cases are supported for satellite sites:
  • A subject is allocated to a satellite site and carries out all visits at the satellite site as part of the study.
  • A subject is allocated to a parent site and carries out some visits at the satellite site as part of the study.

In the October 2009 Guidance [1], the FDA
defines their understanding of ‘adequate supervision of the conduct of an ongoing clinical
trials’.

• ‘For each study site, there should be a distinct individual identified as an investigator who has supervisory responsibility for the site.
• A sub-Investigator at a site, that individual should report directly to the investigator for the site
• The investigator should have clear responsibility for evaluating the sub-Investigator’s performance and the authority to terminate the subinvestigator’s involvement with the study
• Sub-investigator should not be delegated the primary supervisory responsibility for the site
• The investigator should have sufficient time to properly conduct and supervise the clinical trial.

Factors that may affect the ability of an investigator to provide adequate supervision of the conduct
of an ongoing clinical trial at the investigator’s site:
– Conducting a study from a remote (e.g. offsite) location
– Conducting a study at multiple sites under the oversight of a single investigator

The investigator should develop a plan for the supervision and oversight of the clinical trial at the site. Supervision and oversight should be provided even for individuals who are highly qualified and experienced.’’
Satellite centers, which are geographically distant and/or where the PI has delegated supervisory responsibilities to a sub-investigator, will no longer be acceptable under the FDA guidance.

Common Question:-

Is it possible to have a Remote Location?

One of the interesting questions asks whether a “satellite site” would be possible under GCP.

The agency answered the following:

• The term “satellite site” is not defined in FDA’s regulations or guidance.
• In general, an investigator should have a detailed plan for the supervision and oversight of a clinical trial. Conducting a study from a remote (“satellite”) location, is one factor that may compromise the ability of an investigator to provide adequate supervision of the conduct of a clinical trial.
• There should be a subinvestigator responsible for the conduct of the clinical trial at each trial site. Subinvestigators should report directly to the investigator.
• If the “satellite” location is in reasonably close proximity to the one where the clinical investigator normally does business, it could be feasible for him / her to conduct the study at both sites, or at least to adequately oversee the conduct of a subinvestigator at the “satellite site”.
• When the proposed “satellite site” is located far away, or in another city, state, province, this would make it difficult for the clinical investigator to successfully conduct and / or oversee the study at that site. The agency therefore recommends that the proposed “satellite site” choose a different individual to conduct / oversee the study (= completely separate study site rather than a “satellite site”).
• The individual overseeing the study at that new site would need to sign a separate agreement with the study sponsor.

What is a satellite? Or, is it OK for us to send drug to other offices/sites?

Answer: As per “Pharmaceutical Management Branch, CTEP, NCI “

A “Satellite Location” is a local site away from the control area or primary storage area (that is, the place to which PMB shipped the agent).  Any transportation of PMB-supplied agents between the con- trol location and satellite location must remain in the institution’s immediate control.  If delivery of an agent requires use of a secondary carrier (e.g. US postal service, Fed-EX, UPS), the other location is not a satellite.

When investigational agents are received at the control location, they may be transported to satellite locations (originally conceived as within walking distance, sharing staff, and covered by the same IRB). Any transportation must be in the receiving institution’s direct control, and a third party shipper may not be used.  Local satellite institutions or affiliates must be serviced by institution-employed couriers or central pharmacy staff.  CTEP-supplied agents must not be repackaged or forwarded by mail or express courier. The NCI has established policy to maintain validated shipping conditions (and therefore product integrity) for agents used for clinical research to ensure that PMB can track all product immediately should there be a recall to be able to convey other important pharmaceutical information quickly when necessary, and to assist in agent accountability.

Any transportation of investigational agents outside the direct control of the institution receiving the agent is considered secondary distribution.  Secondary distribution violates NCI policy and proce- dures.

•How far away is the satellite in both distance and travel time?  How many patients will need this accommodation?

•Can we work together to develop a mechanism that works for you that will allow us to directly ship agent to your satellite?

•Does the staff member who will transport the agent know that it is considered a dangerous substance by the Department of Transportation if that is the case?

• How will you address the following?

Agent stability issues both during transportation and for any storage at the local site. safety issues (dangerous substance, how to handle a spill) preparation of the patient’s dose under appropriate conditions by appropriately trained staff the need to have someone that can appropriately administer the medication at the site a method for proper disposal of the waste, empty IV bags, etc. a plan for returning unused medication to the central location a back up plan for those instances where a replacement dose may be needed (product damaged, treatment had to be emergently interrupted, etc.) particularly if treatment has been started confirmation that the medication was given (while not a PMB requirement, it is an investigational study requirement)

• a plan for handling missed dose
• a plan for multiple day therapies (are doses driven up each day)
• agent accountability via a DARF

References:-

• “Process of Managing Sites and Contacts for Clinical Trials”.
• For information about creating a site for a clinical trail, see “Creating Sites for Clinical Trials”.
• For information about creating a satellite site for a clinical trail, see “Creating Satellite Sites for Clinical Trials”.
• Will the new FDA guidance impact Satellite Investigator Centres?

New European Regulation on Clinical Trials 31Jan2022

Tags

EU

Regulation (EU) 536/2014 of the Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use (“Regulation”) came into force on 31 January 2022.

The Regulation was adopted by the European Parliament in 2014 and released in May of the same year. It was subsequently officially published in the Official Journal of the European Union on 31 July 2021 and came into force six months after that date.

Aims and benefits

The purpose is to foster innovation and research in the EU, facilitating the conduct of larger clinical trials in multiple EU Member States/EEA countries. 

The Regulation repeals Directive 2001/20/EC and makes sweeping changes to the European rules on conducting clinical trials. Here are some of the most Important changes made. For more detail information you can Read More . Direct Link is provided below.

the new Regulation will make it possible to:-

(i) harmonize the rules and procedures for conducting clinical trials in the countries covered

(ii) enhance the safety of trial participants while ensuring greater reliability and quality of the information collected.

(iii) The Clinical Trials Regulation harmonises the processes for assessment and supervision of clinical trials throughout the EU. 

(iv) The evaluation, authorisation and supervision of clinical trials are the responsibilities of EU Member States and European Economic Area (EEA) countries. 

(v) Prior to the Reg ulation, clinical trial sponsors had to submit clinical trial applications separately to national competent authorities and ethics committees in each country to gain regulatory approval to run a clinical trial.

(vi) The Regulation enables sponsors to submit one online application via a single online platform known as the Clinical Trials Information System (CTIS) for approval to run a clinical trial in several European countries, making it more efficient to carry out such multinational trials. 

(vii) The Regulation also makes it more efficient for EU Member States to evaluate and authorise such applications together, via the Clinical Trials Information System.

(viii) It will also make it simpler to conduct multinational trials and expand existing trials to other CTIS states. This will make the EU/EEA a more attractive location for clinical research and this is essential for scientific development.

The CTIS system:

• enables sponsors to apply for clinical trial authorization in up to 30 European countries with a single online application;
• allows national regulators to collaboratively process clinical trial applications in more than one country, request further information, authorize or refuse a trial and oversee an authorized trial;
• facilitates the expansion of trials to other EEA countries;
• enables transparency and access to information for any party interested in clinical trials conducted in the EEA through a searchable public website.

Other key benefits of the Regulation include:

• improving information-sharing and collective decision-making on clinical trials;
• increasing transparency of information on clinical trials;
• ensuring high standards of safety for all participants in EU clinical trials.

The harmonized electronic submission and assessment process for clinical trials conducted in several Member States will facilitate the conduct of clinical trials within the European Union and improved cooperation, information sharing and decision making between Member States.

IMPORTANT LINKS

• Clinical Trials website
• European Union clinical trials register

Related content

• Clinical Trials Information System
• Development of the Clinical Trials Information System
• Clinical Trials Information System: training and support
• Clinical Trials Information System (CTIS): online modular training programme
• Clinical trials in human medicines 
• Data submission on investigational medicines: guidance for clinical trial sponsors

Related EU legislation

• Clinical Trials Regulation EU No. 536/2014
• Clinical Trials Directive (EC) No. 2001/20/EC (repealed by the Clinical Trials Regulation on 31 January 2022)

EMA EURPPA Human Regulatory Research Development

lexology.com library_New European Regulation on Clinical Trials