Definition of: ”clinical study documents” ICH-GCP
Section 8.1 (Essential documents to run the study)

Essential Documents individually and collectively permit evaluation of the conducted trial and the quality of the outcome. These documents serve to demonstrate the compliance of the investigator, sponsor and monitor with the standards of Good Clinical Practice and with all applicable regulatory requirements.

The ICH-GCP gives responsibility for the documents archiving service of a clinical study essentially to three subjects:
Sponsor
Investigator/Institution
Ethics Committee

Documents to archive under the Investigator – Institution responsibility
ICH-GCP
Section 4.9.4 (Document conservation)

The investigator – institution must conserve the study documents as specified in the Essential Documents for Clinical Study Conduction and by the applicable regulatory requirements.

The investigator – institution must adopt appropriate measures in order to avoid accidental or premature destruction of these documents.

ICH-GCP
Section 1.52 (Definition of “source documents”)

Clinical type
Quality criteria

“Source documents”.
Corresponding to hospital notes and other individual clinical data.
“public acts”.
Containing â€œsensitive” data, for which the privacy law is applied. 

Regarding Administration 
Conformity criteria.

“Regulatory” documents.
Documents that do not include sensitive or individual data.
Uncertain juridical Status.
Not legally bound by sensitive data provisions.

CLINICAL DOCUMENTS
Medical records,
clinical registers,
administrative books,
laboratory notes ,
memoranda,
subject diary,
evaluation forms,
drug accountability log,
registered data with automatic instrumentation,
certified copies,
microfiches,
film negatives,
microfilm,
back-up,
x-ray photography,
subject issues,
pharmacy, laboratories and medical departments’ records.