D.I.C.T - Data Integrity in Clinical Trials

D.I.C.T - Data Integrity in Clinical Trials

Heidelberg, Germany

Course No 16585


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Dr Christa Färber, GMP/GCP Inspector

Frank Henrichmann, Parexel

Dr Marina Mangold, Esculape

Dr Wolfgang Schumacher, Chair of ECA IT Compliance Group, formerly with Roche


During this Course you will get to know the principles of Data Integrity (DI) in the light of GCP requirements. You will learn

  • How to manage hybrid systems with their forms and templates, e.g. (electronic) informed consent, (e)CRF
  • How to maintain data integrity for physical, hybrid and full electronic records
  • How to establish a GCP compliant and pragmatic change control process
  • How poor practices and falsification can be detected in the daily business
  • How to train staff in Good Documentation Practice and Data Integrity
  • How multilingual documents can be managed and controlled
  • How to avoid typical data integrity failures
  • How to prepare for a Health Regulatory Inspection

Speakers from Industry and Authority will show what you need to consider to establish and maintain a GCP/GMP compliant data governance system.


The inspection in the context of clinical trials may cover good manufacturing practices (GMP) as regards the manufacturing of the investigational medicinal products (IMP) or good clinical practice (GCP) for the conduct of clinical trials.
Two corresponding documents are dealing with these inspections:
Implementing Regulation (EU) 2017/556 of 24 March 2017 on arrangements for GCP Inspections: This Regulation lays down detailed arrangements for GCP inspections procedures and requirements regarding training and qualifications of GCP inspectors. The sponsor of a clinical trial and the investigator are to ensure that the clinical trial is conducted in accordance with the principles of GCP. Compliance with the GCP principles, including with standards relating to data integrity, is to be verified by means of inspections. Inspectors shall have the ability to make professional judgments in relation to the compliance with applicable legislation and guidelines and shall be able to assess data integrity.
Commission Delegated Regulation (EU) 2017/1569 of 23 May 2017 on arrangements for GMP-Inspections (as regards IMPs): Ensures conformity with GMP for IMPs and makes provisions on inspections. Regular inspections should be carried out as referred to Regulation (EU) No 536/2014 (CTR) and third country manufacturers should be inspected at least if there is a suspicion that the IMPs are not manufactured by applying quality standards at least equivalent to those applicable in the EU. Inspectors should consider the guidelines on GMP for IMPs for human use. Inspections may be unannounced and Inspectors shall be empowered to examine any documents relating to the object of inspection, make copies of records or printed documents and print electronic records.

In clinical trials, usually large amount of data is collected and this data is more and more electronically recorded and processed. The check of the integrity of data is mandatory and is usually performed by the clinical monitor who, in the past, preferentially reviewed only the documentation, but not the history of data entries. Particular emphasis should be put on the hybrid systems, where data are manually transferred from paper to the electronic application, i.e. from the case record forms (CRFs), a process which is very error prone. If electronic systems (eCRFs) are used for the data entry by the medical doctors involved in the clinical study, the clinical monitor may need to review the correctness of the electronic data, i.e. if data was modified or “cleaned” after the first entry. The risk evaluation of all safety relevant criteria, particularly the identification and assessment of adverse effects/events must have top priority. Furthermore completeness and correct entry of the patients’ visits/phone calls and clinical data by the nurses/doctors, according to the clinical protocol, have to be verified by the monitors. The extent of such additional control activities to verify all clinical data relevant for the study, emphasizing also on the laboratory results, is so far not yet defined by the health regulatory authorities.

In addition, sponsors contract out an increasing number of tasks in clinical trials. One area where sponsors typically lack internal knowledge or resources is the development and maintenance of electronic systems in clinical trials. Such electronic systems are used for randomization and IMP distribution management/accountability (Interactive Response Technology (IRT)) and/or clinical trial data capture (eCRF and ePRO systems). During inspections of commercial as well as academic trials, an increasing amount of deviations from GCP standards have been identified by the inspectors in view of sub-standard contractual arrangements and related procedures. Special consideration should be given on training and quality systems. Experience suggests that vendors accepting tasks on electronic systems are frequently knowledgeable on IT systems and sometimes on data protection legislation, but not necessarily on GCP requirements, quality systems, etc.

The challenges with these tasks are frequently underestimated. The risk-based approach concepts of the new ICH E6 (R2) GCP Guideline, which is valid in the EU as of June 14, 2017, are also applicable for data integrity. Additionally, the revised ICH E6 Guideline contains detailed requirements regarding validation of computer based systems used in clinical trials.

Therefore it is necessary to know the risks regarding data integrity and computerized systems in GCP area and to establish risk management measures to implement reasonable and efficient GCP/GMP compliant global data governance systems.

Target Group

  • Employees involved in designing, conducting, evaluating, and documenting of clinical trials including clinical monitors, nurses and doctors.
  • Validation manager, QA manager, project manager, data manager, and statisticians.
  • Pharmaceutical companies, sponsors, contractors (for example CROs, analytical labs) and vendors for electronic systems (including hosting partner).
  • Inspectors responsible for performing GCP/GMP inspections and needing to understand and assess data integrity.


Data Integrity Principles and their Impact on Clinical Trials

  • Critical Data in the clinical area
  • Standards, regulations and guidelines – What is
  • relevant for clinical data?
  • How to set-up a Data Integrity program – Pragmatic approach
  • Roles and Responsibilities
Responsibilities of Investigator, Sponsor and Monitor
  • Responsibilities of Investigator, Sponsor and Monitor regarding DI: according to current legislation, according to the CTR
  • Inspection findings
Electronic Document Management and Change
  • Control Systems to Ensure Data Integrity
  • Requirements for source documents (e.g. medical records) & identification lists
  • Transfer to eRecords & eDocuments
  • How to establish a compliant and pragmatic change control process
Trial Master File - TMF
  • Requirements for TMFs
  • eTMFs & eTMF systems
  • Transfer to eTMF
Randomization & Trial Supply Management
  • GCP or GMP….what Regulations are really applicable?
  • Why is this area so critical? – a high level risk assessment considering Randomization, Labeling, Packaging, Blinding
  • What are the critical data and how can we safeguard them?
Records – Life Cycle and Data Integrity Issues
  • How to make systems compliant to meet regulatory expectations?
  • Pragmatic approaches for legacy systems
  • Tasks of the IT department
Vendors and Contractors of electronic systems and clinical data management: considerations and pitfalls
  • Training and quality systems, GCP Standards to be followed
  • Status of contracts, distribution of tasks
  • Audits and inspections
  • Compliance with the protocol
  • Information about agreed output
Electronic informed consent and eCRF: Hybrid Systems
  • Second person review for critical areas
  • Do we need to review Audit Trails?
  • Data Integrity compliant practice
GMP / GCP compliant document management
  • Criteria for Data Integrity
  • ALCOA rules
  • eDMS systems and electronic signatures – essential elements
Case Study: Data Integrity in Medical Imaging Studies
A step-by-step analysis of a Data Integrity Issue focusing on
  • Technical and Procedural Controls
  • Risk Assessment & Management for Data Integrity
  • Potential Impacts and Consequences
Can we avoid this in the future?
European Data Protection Regulation 2018 - Impacting Clinical Trials!?
  • Rights of the Data Subject
  • Tasks for the Data Controller and Data Processor
  • IT data security requirements
Participants will analyse typical situations with Data Integrity impact and discuss solutions

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