CRIS and Research Documentation at ADHB
1. Introduction
Clinical records at ADHB are maintained via the Clinical Record Information
System (CRIS). This system involves the digital scanning all clinical records
and documents, which can then be securely viewed by authorised users via
a PC at any geographic location across the ADHB network. Authorised staff
can also download records to a laptop computer at off-site locations.
Clinical records are scanned in full colour (i.e. not black and white). This
ensures a high quality image that matches the original content in the paper
record. Once a document is scanned it cannot be altered in any way*.
The digitised clinical record is stored on a magnetic disc (the primary storage
system) and backed up to an optical disc within seconds of being committed
to the primary system. All systems meet the requirements of FDA 21 CFR Part
11. The information stored on CRIS will be transferred from magnetic/optical
storage to emerging media at appropriate time intervals, as technology
advances.
ADHB uses a ‘scan on demand’ model, whereby existing records are
scanned in their entirety prior to a patient’s booked inpatient or outpatient
visit. Old records that are not reactivated by a new patient visit are not
scanned. Records that have not been scanned will continue to be available
in paper form.
2. Access to CRIS
Where appropriate, ADHB staff are issued with a CRIS User ID and passwords
to facilitate on-line access to required records. Access to hard copy records
is available via the standard record request procedures (i.e. by contacting
the Clinical Record Department on site).
External study monitors are permitted access to specific records for specified
periods. To arrange this, contact the Clinical Records Department on ext.
7274. For all scanned records, the Clinical Record Department will arrange for
the external monitor to be issued with a CRIS logon/User ID and password. It is
ADHB policy not to share your password.
External study monitors are welcome to use the viewing room facility at the
Grafton site. This facility is equipped with PCs to provide access to CRIS. To
book these rooms, contact the Clinical Record Departments at Grafton on
ext. 7274.
* Only authorised clinical record department staff with an appropriate
security level can delete documents in CRIS. All transactions within the system
(document viewing, printing, deletion, etc.) are recorded in the system’s
Audit Log.
CRIS training and support material is available from the Clinical Records site
on the ADHB intranet:
<http://ahsl85_gl/ClinicalRecords/Cris_Training/Training.htm>
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Personal support is also provided via the Clinical Workstation Training &
Support Unit (CWTSU) Helpdesk on ext 27000. Should research sponsors
require further information regarding the storage media, how the data is
backed up and the processes for managing document
deletion/amendment, they should be referred to Linda Fletcher, Manager,
Patient Information Services, ext. 24074.
3. Clinical Trial Alerts
If there is a need to alert others of a patient’s participation in a clinical trial,
then the trial Principal Investigator, or their authorised representative, should
complete a Clinical Alert Notification Form (document order number CR0008)
for each study participant. This form should include:
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the ticked “Clinical Trial” box
the Short Project Title (as per Research Consent Document or
Information Sheet)
the Ethics Committee (or ADHB) study number
a contact name and phone number
the NHI number
The study information sheet
Completed Clinical Alert Notification Forms are sent to the CRD, Building 21,
Grafton. The Alert is added in CMS – CMS informs CRIS that there is an alert on
this patient, but the details of the Alert do not go across to CRIS. CRIS displays
a message to the end-user ‘A Clinical Alert exists for this patient. Please check
documentation in the record / CRIS for details’.
The Alert Notification Form is scanned and can be viewed under the Alerts
Tab (The Alert Notification Form is processed by CRD staff and then comes to
the Scan Centre for urgent processing).
4. Clinical trial documentation
All research related documentation is to be sent to the Scan Centre via the
blue back pocket, used for clinic documentation. The patient’s NHI number
should be on every page. All documentation will be scanned within 24 hours
of receipt by the Scan Centre.
Indexing
All research documentation will be indexed to categories in the mainstream
record, i.e. clinical notes to the clinical notes tab, laboratory results to the
result type, etc.
The exception to this will be anything other than clinic notes, lab results, or
investigations or information and consent forms, e.g. trial worksheets and
other miscellaneous research documents. These documents should be
stamped with a clinic trial documentation stamp.
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Note: This is the responsibility of the research area to ensure these
documents are stamped. Failure to do so may result in errors in indexing if
these documents are not recognised as clinical trial documentation.
Clinical Notes
Research units have the option of developing and using customised barcoded clinical note forms. How to arrange these forms can be discussed with
Sue Guthrie, Health Information Manager, on ext. 4050.
Consent Forms & Information Sheets
All Consent Forms for research participants must be accompanied by the
current approved version of the Information Sheet. The Information Sheet
and Consent Forms are considered a single legal document. These will be
indexed to Consent Form - Clinical Trial and viewable under the Consent tab.
Laboratory Results
Researchers should not send hardcopy ADHB laboratory results for scanning
as all ADHB laboratory results are sent electronically into CRIS. Research areas
should use the clinical notes to document that they have seen a result and
any action that was taken.
5. Corrections to scanned clinical trial documents
The process for correcting documents that have been scanned is to print the
scanned document, make the changes in the standard method (cross-out,
correct, sign, date), then send the revised paper back for scanning. The
revised documentation should be addressed to the CRIS Business
Administrator, Clinical Record Department, Building 21, Grafton.
It is important that the revised documentation is accompanied by a special
note requesting that the original document be deleted and replaced with
the revised documentation.
6. Notification to Sponsors of the move to electronic based records
In November and December 2005 letters were sent out to all the known
sponsors of research (current and past) informing them of the transfer to
electronic based records and that overtime the paper copies would be
destroyed. They were given 8 weeks to respond with any queries or requests.
No responses have been received.
Of note, Clause 9 of the Health (Retention of Health Information) Regulations
1996 provides that there is no requirement to keep information in any
particular form. Information can be retained in what ever form the health
provider deems fit. It is therefore permissible to hold records in paper then
scanned form. Once they have been scanned, these scanned records can
be deemed the official record and the paper copies destroyed.
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7. References
Regulations and guidelines (excerpt from the GCP Journal, April 2003):
a. Retention times are referred to in the Note for Guideline on GCP
(CPMP/ICH/135/95). Section 5.5.11 notes that sponsor-specific essential
documents should be kept for at least two years after the last marketing
application approval in an ICH region and until there are no pending or
contemplated marketing applications there, or at least two years have
elapsed since formal discontinuation of an investigational drug’s clinical
development. Section 5.5.12 says sponsors must notify investigators and
institutions in writing when trial-related documents are no longer needed.
b. EU storage requirements are laid out in the draft Detailed Guidelines on
the Trial Master File and Archiving, which was produced to supplement the EU
clinical trial directive (2001/20/EC). It details the minimum set of documents
to be retained, the quality of the documents to be archived, minimum
standards for storage conditions, media transfer and certified copies and
retention times.
c. US requirements are specified in FDA regulation 21 CFR Part 11. This
provides criteria under which the FDA accepts electronic records, electronic
signatures, and handwritten signatures executed on electronic records as
being equivalent to paper records with handwritten signatures.
d. Health Information Management Service at Stanford University Medical
Center. http://www.clinicaltrials.stanford.edu/med_records.pdf
e. Medical University of South Carolina stating that scanned records may be
destroyed after a period of 6 months:
http://www.musc.edu/uma/compliance/policies/C001.pdf
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