EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2016) XXX  draft  
  
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
on the detailed arrangements for the good clinical practice inspections procedures, 
including the qualification and training requirements for inspectors  
(Text with EEA relevance)   EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
on the detailed arrangements for the good clinical practice inspection  procedures  
pursuant to Regulation (EU) No 536/2014 of the European Parliament and of the 
Council   
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union , 
Having regard to 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, and 
repealing Directive 2001/20/EC1, and in particular Article 78(7)  thereof,  
Whereas:  
(1) Regulation (EU) No 536/2014 lays down  the legal framework for the conduct of 
clinical trials on medicinal products for human use  in the Union to ensur e that the 
rights, s afety and well -being of the subject s are protected and the data generated in 
clinical trials are robust and reliable. In particular  the sponsor of a clinical trial and the 
investigator  are to  ensure that the clinical trial is conducted in accordance with t he 
relevant protocol and the principles of good clinical practice. Compliance with the 
applicable legal requirements, the protocol and the principles of good clinical practice, 
including with standards relating to data integrity and ethical conduct of the clinical 
trial, is to be ve rified by means of inspections  conducted under the responsibility of 
the Member State  where the inspection takes place .  
(2) The inspection in the context of clinical trials may concern good manufacturing 
practices as regards the manufacturing of the investigational medicinal products or 
good clinical practice  as regards the conduct of clinical trial s.  Article 63 of Regulation 
(EU) No 536/2014 em powers the Commission to adopt d elegated a cts specifying the  
detailed arrangements for good manufacturing p ractice inspections  as regards 
investigational medicinal products . Therefore, this Regulation should  only lay down 
detailed arrangements  for good clinical practice  inspections procedures and 
requirements regarding training and qualificati ons of good clinical practice  inspectors . 
(3) Member States may conduct inspections of clinical trials performed in third countries 
either because a clinical trial is related to a clinical trial authorised in the Union  or 
because the data of the clinical trial  is being  referred to in a clinical trial authorisation  
application  in the Union . Those inspections sh ould allow  verify ing whether such 
clinical trial s were conducted in accord ance with  standards equivalent to Union  
standards.  Inspections of clinical trial s in third countries may also be conducted i n 
order to verify whether  the clinical trials , whose results  are referred to in marketing 
authorisation applications  in the Union , meet the ethical requirements set  out in 
Regulation (EU) No 536/2014 . Therefore , provisions on detailed arrangements for the 
                                                 
1 OJ L 158, 27.05.2014, p. 1.  EN 3   EN inspection procedures should apply also to inspections conducted outside the Union  in 
accordance with Regulation (EU) No 536/2014 .  
(4) The International Conference on Harmonisation ("ICH") reached a consensus in 199 5 
to provide a harmonised approach for good clinical practice. Pursuant to Article 47 of 
Regulation (EU) No 536/2014, the ICH guidelines should be appropriately taken into 
account by the sponsor when drafting the clinical trial protocol and conducting the 
clinical trial. To the extent that those guidelines are compatible with the relevant 
Union law and EU guidelines, inspectors  should refer to t he ICH guidelines , taking 
into account  the characteristics of each trial .  
(5) Member States should be required to set up quality systems to ensure  that the 
inspection procedures  are observed and consistently monitored . A well-functioning 
quality system  should comprise an organi sational structure, clear processes  and 
procedures , including the standard operating procedures  to be followed  by inspectors  
when performing their tasks , clearly defined details of the inspectors' duties and 
responsibilities and ongoing training requirements , as well as adequate  resources and 
mechanisms which aim at eliminat ing non-compliance .  
(6) It is necessary to enable  inspectors to ensure the practical effectiveness of provisions  
on good clinical practice . Th at objective should be  reflected in the minimum 
requirements for the qualification of inspectors, in particular as regards their education 
and training. For the same reasons, detailed rules on inspection procedures should be 
laid down.  
(7) In order to safeguard the effectiveness of inspection, the inspectors should be granted 
the necessary powers of access to the premises and data.  This includes in particular 
any laboratory used for analysis in the clinical trial, any contract research 
organisation’s facilities or the sponsor's premises.  They should also be empowered to 
contact the trial subjects in justified cases . 
(8) In order to ensure the compliance with arrangements for good clinical practice 
inspections  and in  accordance with Article 77 of Regulation (EU) No 536/2014  
Member States should take corrective measures  if necessary. When during an 
inspection a major non -compliance or breach is identified, or the inspectors' 
investigatory powers are not recognised by the sponsors, Member States should have 
recourse to penalties.  
(9) In order to ensure the protection of confidential information, in particular personal data 
of clinical trial subjects related to t he health as well as commercially confidential 
information,  the inspectors and experts involved in inspections should be bound by the 
highest standards of confidentiality and the applicable requirements of the Union law, 
national laws and international agr eements. The  inspectors and experts involved in 
inspections should  comply with the requirements of Directive 95/46/EC  of the 
European Parliament and of the Council2 when processing personal data . 
(10) Commission Directive 2005/28/EC3 should be repealed  in order  to ensure that only 
one set of rules applies to  the conduct of good clinical practice inspections of clinical 
                                                 
2 Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the 
protection of individuals with regard to the processing of personal data and on the free movement of 
such data (OJ L 281, 23.11.2015 , p. 31).  
3  Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for 
good clinical practice as regards investigational medicinal products for human use, as well as the 
requirement for authorisation of the manufact uring or importations of such products (OJ L 91, 9.4.2005, 
p.13).  EN 4   EN trials, including clinical trials governed by Directive 2001/20/EC  of the European 
Parliament and of the Council4. However, i n order to ensure co nsistency with Article 
98 of Regulation (EU) No 536/2014 setting up  a transit ional  period maintaining , as 
regards certain request s for authorisation of a clinical trial , the applica bility  of 
Directive 2001/20/EC , Directive 2005/28/EC  should , with the excep tion of its 
Chapters 5 and 6 referring to good clinical practice inspection procedures and 
inspectors,  remain applicable during that transit ional period to all clinical trials 
authorised on the basis of Directive 2001/20/EC .  
(11) This Regulation should become applicable at the same time as Regulation (EU) No 
536/2014.  
(12) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee  on Medicinal Products for Human Use ,  
 
HAS ADOPTED  THIS REGULATION:  
 
 
CHAPTER I 
GENERAL PR OVISIONS  
 
Article 1  
Scope  
This Regulation applies to inspections of:   
(a) clinical trials conducted in the Union , including clinical trial sites related to th ose 
trials but located outside the Union ; 
(b) clinical trials referred to in the applications for clinica l trial  authorisations pursuant 
to Article 25(5) of Regulation (EU) No 536/2014;  
(c) clinical trials conducted in third countries and referred to in marketing authorisation 
applications in the Union . 
 
 
Article 2  
Timeframe for  inspections   
Inspections may take place in any of the following circumstances : 
(a) before, during or after the conduct of clinical trial;  
(b) as part of the verification of applications for marketing authorisation;  
(c) as a follow -up to the granting of a marketing authorisation .  
 
Article 3  
Quality s ystem  
                                                 
4 Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the 
approximation of the laws, regulations and administrative provisions of the Member States relating  to 
the implementation of good clinical practice in the conduct of clinical trials on medicinal products for 
human use (OJ L 121, 1.5.2001, p. 34).  EN 5   EN 1. Each Member State  shall set up a properly designe d quality system  ensuring that the 
inspection procedures are observed and consistently monitored .  
 
Member States shall maintain those quality systems up to date.  
  
2. Each inspector shall have acce ss to and comply with  standard operating procedures,  details 
of the ir duties, responsibilities and training requirements.  
 
 
CHAPTER II 
INSPECTORS  
 
Article 4  
Qualifications, training and experience  
1. Inspectors shall have completed education at university level, or have equivalent 
experience, in medicine, pharmacy, pharmacology, toxicology or other fields relevant to the 
principles of good clinical practice.  
 
2.  Inspectors shall receive appropriate training, including participation in inspections . Their 
training needs , necessary to maintain or improve their skills,  shall be assessed regularly  by 
person appointed for that task .  
 
3. Inspectors shall have knowledge of principles and processes that apply to the development 
of medicinal products and clinical re search and have knowledge of applicable Union and 
national legislation and guidelines on the conduct of clinical trials  and the granti ng of 
marketing authorisations.  
 
4. Inspectors shall have the ability to make professional judgments in relation to the 
compliance with applicable Union  and national legislation  and guidelines . They shall be able 
to assess data integrity as well as aspects related to ethical conduct of clinical trials.  
 
5. Inspectors shall be familiar with the procedures technical methods  for the recording and 
management of clinical data, and with the organisation and regulation of the healthcare 
system s in the relevant Member States and, where appropriate, in third countries.  
 
6. Inspectors shall be able to  assess the degree of risk as regard s the  safety of the subject s 
enrolled in the clinical trial  as well as the data integrity .  
 
7.  Inspectors shall be aware of the applicable rules  as regards confidentiality  and protection 
of personal data . 
 
8. Member States shall keep records of the quali fications, training and experience of each 
inspector and maintain th ose records up -to-date for as long as inspector is in active duty . 
 
Article 5  
Conflict of interest and impartiality  EN 6   EN 1. Inspectors shall be free from any influence which could affect their impartiality or their 
judgement.  
 
2. Inspectors shall not have conflicts of interest. In particular, they shall be independent of all 
of the following parties:  
(a) the sponsor ; 
(b) the investigators involved  in the clinical trial;  
(c) persons financing the clinical tr ial; 
(d) any other party involved in the conduct of the clinical trial.  
 
3. Each inspector shall make an annual declaration of their financial interests and other links 
to the parties to be  potentially  inspected. Th at declaration shall be taken into considerat ion for 
the purposes of  assign ing an inspector to a specific inspection.    
 
 
CHAPTER III 
INSPECTION PROCEDURES  
 
 
Article 6  
Subject -matter of inspections  
1. Inspectors shall verify the compliance with the requirements of Regulation (EU) No 
536/2014 , includi ng protection of the rights and wel l-being  of the clinical trial subjects , the 
quality and integrity of data generated in clinical trial,  the compliance with principles of good 
clinical practice, including the ethical aspects  and the relevant national legi slation.  
 
 
Article 7  
Procedures to be established by Member States  
  
1. Member States shall establish the relevant procedures for at least  the following:  
(a) appointing experts to accompany inspectors , if additional expertise is required for an 
inspection ; 
(b) arranging inspections outside the Union ; 
(c) verification of good clinical practice compliance, including the modalities for 
examining the study management procedures and the conditions under which the 
clinical trial is planned, performed, monitored and recorded , as well as follow up 
measures , such as a review of an analysis of the root cause of a significant non -
compliance and verification of corrective and preventive actions implemented by the 
sponsor . 
Member States shall make those procedures and rules publicly  available.  
 
2. Member States shall also define the powers of experts appointed to accompany inspectors .  
 
 
Article 8  EN 7   EN Unannounced inspections  
 
The inspections may, where  necessary, be carried out unannounced.  
 
 
Article 9 
Collaboration between Member States  
1. Member States  shall collaborate with each other, with the Commission and with the 
European Medicines Agency to develop and improve commonly recogni sed standards  of good 
clinical practice inspections . This collaboration may take the form of joint inspec tions, agreed 
processes and procedures and sharing of experience and training.  
 
2. The Commission shall make publicly available any guidance documents on the commonly 
recognised standards for the conduct of inspections, developed in collaboration  with Memb er 
States and the  European Medicines Agency . 
 
3. The European Medicines Agency shall process and make available to Member States 
information on  inspections that are envisaged, scheduled, or conducted, in order to assist 
Member States  to ensure the most eff icient use of inspection resources  when planning their 
inspections . 
 
4. Member States may request assistance from the national competent authority of another 
Member State in the matter of inspection.  
 
 
Article  10 
Power s of inspectors  
1. Inspections shall be carried out by inspectors  appointed by Member State s.  
 
In order to ensure the availability of necessary skills for each inspection,  Member States may 
appoint teams of inspectors and appoint experts with appropriate qualifications to accompany 
inspector s.  
 
2. Inspectors shall be entitled to inspect the clinical trial sites, documents, facilities, records , 
including individual patients' records , quality arrangements, data and any other  resources and 
entities that are deemed by the competent authority  to be related to the clinical trial.  
 
3. When performing an inspection, the inspectors shall be empowered to enter into sites , other 
related premises,  and to access to data , including individual patients' records .   
 
4. Inspectors shall be entitled to make co pies of records and hardcopies, print outs of 
electronic records and take photos of premises and equipment.  
 
5. Inspectors shall  be entitled to ask any representative or member of staff of the inspected 
entity  and any party involved in the clinical trial for explanation s relating to the subject matter 
and purpose of the inspection and to record the answer.  
 EN 8   EN 6. Inspectors shall be empowered to contact the trial subjects  directly , in particular  in case of 
reasonable suspicion that they were not informed adeq uately of their participation in the 
clinical trial.  
7. Member States shall provide inspectors with suitable means of their identification.  
 
8. Member States shall establish a legal and administrative framework to ensure that 
inspectors from other Member States, on-request and where appropriate,  have access to sites, 
any premise of any entity related to the clinical trial as well as to related data.  
 
Article 11 
Recognition of inspection conclusions  
Inspectors shall carry out inspections on behalf of the Un ion. The results of those inspections 
shall be recognised by all Member States.   
 
In case of divergences between Member States in rel ation to the verification of compliance 
with the applicable legislation, the Member States, or the European Medicines Agenc y within 
the framework of its powers as provided for in Regulation (EC) No 726/2004 , shall inform the 
Commission. The Commission, after consulting those Member States and the European 
Medicines Agency, may request a new inspection . 
 
Article 1 2 
Resources  
Member Sates shall appoint a n adequate number of inspectors to ensure effective verification 
of compliance of clinical trials with applicable requirements , as well as the timely reporting of 
inspection findings.  
 
 
Article 13 
Inspection reports and records  
Without prejudice to the obligation to submit the inspection reports via the EU Portal in 
accordance with Article 78(6) of Regulation (EU) No 536/2014, Member States  shall keep for 
at least 25 years relevant records of national inspections as well as of the inspections  
performed  outside their territory , including information on the outcome of the inspection as 
regards good clinical practice compliance status  as well as any action taken by the sponsor or 
Member State  in the  follow up  of the inspection . These  records shall  not contain personal 
data of clinical trials subjects.  
 
Article 14 
Confidentiality  
The inspectors and experts appointed to the inspection team  shall maintain the confidentiality 
of information  to which  they gain access as a result of good cl inical practice inspections .  EN 9   EN  
CHAPTER IV  
FINAL PROVISIONS  
Article 15 
Repeal  
Directive 2005/28/EC is repealed from the date referred to in the second paragraph of Article 
17. 
 
Article 16 
Transit ional provisions  
 
Directive 2005/28/EC , except  for its Chapter s 5 and 6,  shall continue to apply  to the clinical 
trials governed by Directive 2001/20/EC pursuant to  Article 98 of Regulation (EU) 536/2014 . 
 
  
Article 17 
Entry into force  
This Regulation shall enter into force on the twentieth  day following that of its publication in 
the Official Journal of the European Union . 
It shall  apply from six months after the date of publication in the  Offic ial Journal of the 
European Union  of the notice referred to in Article 82(3) of Regulation (EU) No 536/2014.  
This Regulation  shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
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