SOP/ACH/001 Data Collation and Record Keeping in Analytical Chemistry
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For each project, there are normally 4 files:-
File 1:
Contains the protocol, amendments to protocol and any correspondence with the client.
File 2:
Contains any or all of the following:-
Ethical Review Committee submission
Minutes of Ethical Review Committee
Human study protocol
Animal study protocol
Human volunteer consent forms
Clinical examination forms
Dosing/Bleeding record forms
Animal/Human clinical chemistry/haematology data.
File 3:
Contains any or all of the following:-
Interim reports
Draft reports
Amended draft reports
Final report
Requisition slip for release of final report
Miscellaneous illustrations (not original data).
File 4:
Contains Raw Data:-
Laboratory notebooks
Chromatograms
Absorption and mass spectra
Scintillation counter output
Autoradiograms.