Development↦Documents↦Required Documents↦Study Documents
What is it? Why is it important?
In studies many different types of documents come into play. Collectively they allow for the evaluation of study conduct, especially with respect to participant safety and the quality study data.
Study documents include:
- Essential documents: which are commonly referred to as regulatory documents necessary to maintain study approval, such as:
- The study protocol, the PIS and ICF, various logs, contracts, insurance, correspondence, and various reports (e.g. annual-, clinical study report)
- CRF: tool designed to collect data from study participants (e.g. CRFs come in paper and electronic form)
- Monitoring Plan: a document that describes the study monitoring strategy
- Quality documents: Ensure that studies are conducted in a harmonised and reproducible manner (e.g. SOPs, WIs, study processes, laboratory manuals, checklists)
Additional documents needed during study conduct are:
- Source data: All information in original records and certified copies of original records of clinical findings, observations, or other activities in a study necessary for the reconstruction and evaluation of the study. Source data are contained in source documents (original records or certified copies)
- Source documents: original documents, data, and records (e.g. hospital records, laboratory notes, subjects’ diaries, pharmacy dispensing records etc.)
Upon study termination, study documents must be archived during a specific period (e.g. as legally required or as defined in the study protocol). This allows the set-up and conduct of the study to be retraced at some later date. During the archiving period, both EC and RA (e.g. Swissmedic) can request an audit or inspection of study documents.
What do I need to do?
In order to ensure the safety, data quality and the smooth running of a study, requires that both the SP-INV and Site-INV define and generate study required documents. This includes:
- Essential documents
- Quality documents. Ensure quality documents are:
- Some document are submitted to health authorities for approval (e.g. EC). They can only be implemented in the study after approval has been received.
- During study conduct, ensure study documents are filed on an ongoing basis. Delays in document filing carry the risk of losing the required study oversight. This can significantly jeopardize the quality and safety of the study. The set-up of a DMS is here key.
Filing of study document:
- Essential documents are filed prior, during and after study completion in the ISF (by the Site-INV) or TMF (by the SP-INV)
- Quality documents must remain accessible at all times to study staff responsible for performing various study tasks. If not filed in the TMF/ISF include a note that describes where these documents are kept
- Data entry in the CRF should be in close proximity of data collection (e.g. participant study visit) or incoming results (e.g. laboratory, x-rays, CT)
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
ICH GCP E6(R2) – see in particular guidelines
- 1.23 Essential Documents definition
- 8 Essential Documents for the Conduct of a Clinical Trial