Conduct↦Data Management↦Data Processing↦Interim Lock
What is it? Why is it important?
An interim database (eCRF) lock (IL) is performed before all data has been collected. It is mainly due to:
- Specification defined in the study protocol for to safety or efficacy concerns
- Requests forwarded by the DSMB and/or Ethics Committee (EC).
- Data cleaning processes during long term studies
Safety and efficacy information provided by the interim analysis will help to determine whether the study should be continued, adapted or terminated.
Data analysis not based on specifications in the study protocol carries the risk of corrupting the study, as the researcher is no longer an independent bystander but become biased as to study outcome of the study.
What do I need to do?
As a SP-INV in collaboration with the Data Manager (DMan) and Statistician:
- Follow IL timelines as defined in the study protocol
- Inform participating study sites of an upcoming IL, including the expected timing
- Ensure IL procedures (e.g. defined in collaboration with the DMan in a SOP or WI ) are complied with, such as:
- Data cleaning and query resolution are finalised before IL
- Correct intermediate data export procedures for transfer to a statistical software system
- Data remains blinded to the SP-INV and statistician during data evaluation
Database locks during study conduct can put increased pressure on site staff and people involved in data collection and management. In order to ensure data quality at the time of IL, train and remind staff to enter data consistently and in a timely manner.
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(R2) – see in particular guidelines
- 4.5 Cmpliance with the protocol
- 5.5. Trial Management, data handling, and record-keeping