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 PID and ICF, various logs, contracts, insurance, correspondence, and various reports (e.g. yearly-, 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, processes, manuals, checklists)

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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 can request an audit or inspection of study documents.

What do I need to do?

In order to ensure the safety, quality and 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:
    • Compatible with directives given in the law
    • Subjected to test runs to ensure planned processes are feasible
    • Reviewed for applicability and improved as required
  • Some document are submitted to health authorities for approval. 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.

More

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

References

ICH GCP E6(R2) – see in particular guidelines

  • 1.23 Essential Documents definition
  • 8 Essential Documents 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
  • 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 Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

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

Please note: the Easy-GCS tool is currently under construction.