Download trial data - Lancashire Care NHS Foundation Trust

TRIAL DATA
COLLECTION AND ENTRY
STANDARD OPERATING PROCEDURE NO SOP 07
DATE RATIFIED Sep 2014
NEXT REVIEW DATE Sep 2016
POLICY STATEMENT/KEY OBJECTIVES:
This SOP details the process for collection of trial data and the completion of
Case Report Forms.
POLICY AUTHOR: Katie Glickman; Research Facilitator
Page 1 of 5
09-09-2014
Final V2.0
Corporate Directorate
Chairman: Mr Steve Jones
Chief Executive: Professor Heather Tierney-Moore OBE
BACKGROUND
In the International Conference of Harmonisation Good Clinical Practice (ICH
GCP) guidelines, a Case Report Form (CRF) is defined as ‘a printed, optical
or electronic document designed to record all of the protocol required
information to be reported to the sponsor on each trial subject.’ The trial
sponsor/office issue guidance on how data should be recorded on the CRF.
Investigators are required to comply with this guidance. Documentation of
information in the CRF should be accurate, complete, legible and collected
and submitted to the trial sponsor/office in a timely fashion. Compliance with
the Data Protection Act, 1998 is mandatory. Patient identifiable information
on the case report form (CRF) should not be disclosed to a third party, unless
a patient has consented to this disclosure. In all correspondence the patient’s
identity must be anonymised using their trial Identification code. The subject
enrolment log in the trial investigator site file should be used to record each
patient’s name and trial Identification code. CRFs should be stored securely
in a locked cupboard, filing cabinet or office. CRFs must only be completed
by authorised staff whose signature is included on the delegation log in the
trial investigator site files and has been signed off by the Principal Investigator
(PI) prior to patient/research staff interactions.
See SOP 09 Roles,
responsibilities and delegation of duties.
PURPOSE
This SOP details the process for completion of CRFs and the required data to
be collected for the following studies within LCFT:
-
CTIMPS
-
Trust sponsored clinical trials
-
Interventional studies
PROCEDURE
A sample CRF should be kept in the investigator site file along with
superceded copies clearly marked as such. Where forms are downloaded
from a trial website, a sample copy should be printed and filed in the trial
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09-09-2014
Final V2.0
Corporate Directorate
Chairman: Mr Steve Jones
Chief Executive: Professor Heather Tierney-Moore OBE
investigator site file. CRFs should only be completed/corrected by individuals
whose name, initials and signature appear on the delegation log. The trial
sponsor/office may provide a delegation log for completion. At the patient
visit, all data required by the protocol should be recorded in the study case
report forms from the patient medical notes and the details of the research
trial should be documented in the patient medical notes. These entries should
be signed and dated in the trial documents.
To facilitate the monitoring
process, ensure that the following are recorded in the notes:

Patient eligibility, date of consent and date of randomisation/
enrolment

Dose and/ or therapy modifications

Adverse events, concomitant medications, inter-current illnesses

All visits that subjects fail to attend, tests that are not conducted,
examinations not performed

All withdrawals of enrolled subjects
Data recorded on the CRF that are derived from the subject’s medical notes
should be consistent with the medical notes. Any discrepancies should be
explained on the CRF or in the medical notes.
Data entry
Entries onto the CRF must comply with the instructions supplied by the trial
sponsor/office.
Unless otherwise instructed by the trial sponsor/office, all
entries:

Must be legible

Written in black ink

If CRFs are printed on carbonless duplicated paper, ensure that
a suitable separator is inserted

Never leave blank spaces.
If data is not available write
unknown, missing, test not done, as defined by the trial CRF
completion guidelines.
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09-09-2014
Final V2.0
Corporate Directorate
Chairman: Mr Steve Jones
Chief Executive: Professor Heather Tierney-Moore OBE
Unless instructed otherwise by the trial sponsor/ office, changes or corrections
to the CRF should be made as follows:
o Cross out the incorrect entry with a single line, ensuring that it is
still visible
o Enter the correct data, giving an explanation for the correction, if
necessary
o Initial and date the correction
o Never use correction fluid
o Write in black ink
Finalisation of the CRF
All source documents requiring a PI signature should be dated and signed on
completion by the PI or other authorised personnel whose signature is
included on the delegation log.
Completed and signed CRFs should be
returned within the timelines specified by the trial sponsor/office or within two
weeks of the trial subject’s visit, whichever is the sooner, unless they are
collected by the sponsor at monitoring visits and audit.
A covering letter
should be included with the completed CRFs and a copy kept in the trial
investigator site file. A copy of all completed CRFs must be retained as part
of the trial investigator site file; this may be in the form of electronic records.
Copies of the medical notes and/ or reports of investigations for trial subjects
should only be kept with the CRF if requested by the trial sponsor/office.
Data queries
Data queries should be resolved, signed and dated and returned within the
timelines specified by the trial sponsor/office or within two weeks. Any delays
in responding to data queries should be reported to the trial sponsor/office. A
copy of all data queries and responses to the trial sponsor/ office should be
kept with the CRF.
Research teams experiencing any difficulties in
completing data queries in a timely manner should inform the sponsor.
Page 4 of 5
09-09-2014
Final V2.0
Corporate Directorate
Chairman: Mr Steve Jones
Chief Executive: Professor Heather Tierney-Moore OBE
OTHER
RELATED
PROCEDURES,
POLICIES,
LEGISLATION
OR
GUIDANCE
ICH GCP
Research governance framework, 2nd edition 2005
EU Directive 2001/20/EC
GLOSSARY
Lancashire Care Foundation Trust (LCFT)
International Conference of Harmonisation Good Clinical Practice (ICH GCP)
Case Report Forms (CRFs)
Page 5 of 5
09-09-2014
Final V2.0
Corporate Directorate
Chairman: Mr Steve Jones
Chief Executive: Professor Heather Tierney-Moore OBE