Your Easy Guide to Clinical Studies

Based in the European Medicine Agency (EMA) findings that are not-met are categorised – as follows:

Critical:

• Condition, practices or processes that adversely affect the rights, safety or well-being of the subjects and/or the quality and integrity of data
• Critical observations are considered totally unacceptable
• Possible consequences: rejection of data and/or legal action required
• Remark: observations classified as critical may include a pattern of deviations classified as major

Major:

• Condition, practices or processes that might adversely affect the rights, safety or well-being of the subjects and/or the quality and integrity of data
• Major observations are severe deficiencies and are direct violations of GCP principles
• Possible consequences: data may be rejected and/or legal action required

• Observation classified as major may include a pattern of deviations and/or numerous minor observations

Minor:

• Condition, practices or processes that would not be expected to adversely affect the rights, safety or well-being of the subjects and/or the quality and integrity of data.
• Possible consequences: observations classified as minor indicate the need for improvement of conditions, practices and processes.
• Many minor observations may indicate poor quality and the sum might be equal to a major finding with its consequences.

EXAMPLE OF A FINDING AND ITS MANAGMENT

The Finding: A study participant did sign the Informed Consent Form (ICF) two days prior to the Site-INV. Thus, the study participant and Site-INV did not date and sign the ICF on the same day.

Criteria: Based on the SOP "Informed Consent Procedures", the study participant and the Site-INV must jointly date and sign the ICF on the same day, during a scheduled study visit.  Process aim: at the visit the participant is informed about the study, enabling him/her to ask questions needed to decide whether to participate in the study.

Route cause analysis:

• The study participant was informed about the study during a hospital visit (not study related), and was asked to take the ICF home for further evaluation. Upon return to the clinic participants had already signed the ICF.
• The Site-INV, responsible for participant recruitment, was not trained on the required SOP "Informed Consent Procedures", and was therefore not aware of the need to jointly sign the ICF, together with the participant, on the same day.

Defined CAPA to prevent re-occurrence of finding: 

• Train the Site-INV on the SOP "Informed Consent Procedures"
• Update the SOP "Informed Consent Procedures" to include the event that a participant has pre-dated and signed the ICF, to include the process of having the participant re-sign the ICF on the day of study inclusion, together with the Site-INV

• Basel, Departement Klinische Forschung (DKF), dkf.unibas.ch

• Lugano, Clinical Trials Unit (CTU-EOC), ctueoc.ch

• Bern, Department of Clinical Research (DCR), dcr.unibe.ch

• Geneva, Clinical Research Center (CRC), crc.hug.ch

• Lausanne, Clinical Research Center (CRC), chuv.ch

• St. Gallen, Clinical Trials Unit (CTU), h-och.ch

• Zürich, Clinical Trials Center (CTC), usz.ch