What is it? Why is it important?

In studies many different types of documents or records come into play, and include:

  • Essential documentscommonly referred to as regulatory documents needed for study conduct, records include the:
    • Study protocol: describes the implementation of the study
    • Patient Information (PIS) and Consent (ICF): manages patient information, recrutement, and consent
    • Various documents/records:  logs, contracts, insurance, correspondence,
    • Case report Form (CRF): a paper or electronic tool designed to collect study data
    • Monitoring Plan: describes the study monitoring strategy
    • Statistical Analysis Plan: describes the study statistical strategy
    • Data Management Plan: describes the study data management strategy
    • Reports: generated during study conduct and at study conclusion (e.g. annual-, clinical study report)
  • Quality documents/records: Ensure that the study is conducted in a harmonised and reproducible manner (e.g. SOPs, WIs, study processes, laboratory manuals, pharmacy, checklists)

 

Prior to implementation, some essential documents/records require Ethics Committee (EC) and if applicable Swissmedic and “Federal Office of Public Health” (FOPH) approval.

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Additional documents needed during study conduct are:

  • Source documents: are original documents/records (i.e. including their certified copies) providing information on the study`s clinical findings, observations, or other study activities, necessary for the reconstruction and evaluation of the study (e.g. hospital records, laboratory notes, subjects’ diaries, pharmacy dispensing records)
  • Source data: is the comprised information provided by the source documents of the study

 

Upon study termination, study documents/records must be archived (i.e. for a duration legally required or as defined in the study protocol). This is important in order for the study to be retraced at some later date.

 

During the archiving period, both the Ethics Committee (EC) and Swissmedic can request an audit or inspection of the study`s source data / documents.

What do I need to do?

As a SP-INV, define and generate the required study documents, such as:

  • Essential documents: They are filed prior, during and after study completion in the ISF (by the Site-INV) or TMF (by the SP-INV)
  • Quality documents: They must remain accessible at all times to study staff responsible for performing delegated study tasks. If not filed in the TMF/ISF include a note that describes where these documents are kept

 

Define processes that ensure that during study conduct:

  • Data entry (i.e. in the study database) is done in close proximity to data collection (e.g. participant study visit), or incoming results (e.g. laboratory, x-rays, CT). Delays increase the risk of data errors and missing data, jeopardizing data quality.
  • Study documents/records are filed on an ongoing basis (e.g. DMS). Delays carry the risk of losing study oversight, jeopardizing participant safety and data quality

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

  • Glossary: Definition essential records
  • Glossary: Definition Source records
  • 3.16.3 Record keeping and retention
  • Appendix C. Essential records for the conduct of a clinical trial
Abbreviations
  • CRF – Case Report Form
  • CTU – Clinical Trials Unit
  • CT – Computed Tomography
  • DMS – Document Management System
  • EC – Ethics Committee
  • ICF – Informed Consent Form
  • ICH-GCP – International Council for Harmonisation - Good Clinical Practice
  • ISF – Investigator Site File
  • PIS – Participant Information Sheet
  • RA – Regulatory Authorities
  • Site-INV – Site Investigator
  • SOP – Standard Operating Procedure
  • SP-INV – Sponsor Investigator
  • TMF – Trial Master File
  • WI – Working Instruction
Development ↦ Documents ↦ Required Documents ↦ Study Documents
Study
Basic

Provides some background knowledge and basic definitions

Basic Monitoring
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Statistic Methodology
Concept Drug or Device
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Statistic Methodology
Set-Up Quality and Risk
Set-Up Drug or Device
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Statistic Methodology
Conduct Drug or Device
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Drug or Device
Current Path (click to copy): Development ↦ Documents ↦ Required Documents ↦ Study Documents

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