Conduct↦Monitoring↦Routine Monitoring Visit↦Findings
What is it? Why is it important?
Findings are inconsistencies or problems found during monitoring, such as:
- Data enterd into the eCRF of the study database (CDMS) does not match the Source Data (SD)
- Data is incomplete or missing
- Study staff is not trained
- Responsibilities are not clear
- Documents are used that are outdated or have not been approved by the Ethics Committee (EC), and if applicable RA (e.g. Swissmedic)
- Irregularities exist in the Informed Consent (IC) process
- Safety documentation is missing, or there is an unacceptable delay in safety reporting
- The therapeutic product under investigation (IMP / IMD) is incorrectly handled (e.g. incorrect temperature storage, unrestricted access, incomplete product accountability-log)
The severity of a finding depends on its potential negative impact on:
- The right and safety (i.e. study risk-benefit) of study participants
- The confidentiality and quality of study data.
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Findings can be:
- GCP deviations: the finding does not follow guidelines as stated in ICH GCP (ClinO studies)
- Deviations from the study protocol: tasks required by the protocol are not done, or alternative tasks not covered by the protocol are performed
- Deviations from local laws (e.g. Swiss laws) and regulations (e.g. ISO 14155 for medical device studies).
What do I need to do?
If you are the study monitor:
- Document all findings in the monitoring report that are to be reviewed and assessed by the SP-INV
- Ask the site staff to make immediate corrections to simple findings
- Consult with the site to understand the root cause of more complicated findings and discuss applicable strategies to correct findings and prevent any reoccurrence (e.g. CAPAs)
- Discuss findings with the SP-INV. Findings that systematically remain unresolved during subsequent RMVs may lead to a protocol amendment
Findings to be reviewed by the SP-INV of the study are listed in the monitoring report. It is up to the SP-INV to determine the seriousness of any findings and define appropriate steps. In the event of serious findings, jeopardising participant safety and or data quality, the SP-INV may decide to close a study site..
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Findings might result in a protocol amendment. It is important to note that a protocol amendment, especially a substantial one, can have unwanted consequences on how a study is run.
An amendment can seriously delay the study because an amendment:
- Must be approved by the Ethics Committee (EC) and, if applicable, the RA (e.g. Swissmedic) prior to implementation. This will delay the study as well as generate additional costs
- Requires relevant staff to be retrained
- May require participants to re-consent to study procedures, which carries a risk that participants drop-out of the study
Make sure to invest sufficient time needed to develop the study protocol. This can avoid unnecessary amendments later on during study conduct.
Hasty and inadequate planning, significantly increase the risk of introducing inconsistencies in the study protocol.
Example of a protocol amendment
Based on an implemented study protocol, collected blood volumes were found to be inadequate for the planned analysis. In order to be able to collect additional blood from participants, the SP-INV must first complete both a protocol and a PIS/ICF amendment. In addition, prior to implementation the amendments will have to be approved by EC and if applicable RA. In addition, participants have to consent to the extra blood draw.
Where can I get help?
Your local Research Support Centre↧ can assist you with experienced staff regarding this topic
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
References
ICH GCP E6(R3) – see in particular guidelines
- Glossary: definition monitoring
- Glossary: definition monitoring report
- 3.10.1.3 Risk control
- 3.11.4 Monitoring
- 3.11.4.5 Monitoring activities
- 3.11.4.5.1 Communication with parties conducting the trial
ICH E8 – see in particular guideline
- 6.1 Study conduct
- 6.2.1 Safety monitoring
ISO 14155 Medical Device – see in particular section (access liable to costs)
- 9.2.4 Monitoring