PURPOSE
To describe the procedure for entering research information to the Electronic Patient Record (EPR) for research studies which are actively running in XXX Ltd.
SCOPE
This SOP applies to Investigators and study teams entering information to the EPR for research participants.
RESPONSIBILITIES
It is the responsibility of the Investigator, or designee, to;
- Document information pertinent to a patient’s clinical care in the patient’s EPR (agreeing the location within the EPR with the wider research team) either via direct entry into TRAK, or scanning of paper notes,
- Verify copies of paper notes as a true copy of the original,
- Send paper notes to Health Records for scanning or ensure authorisation has been granted by XXX Ltd for self-scanning of paper notes,
- Check the eCasenote to ensure the scanned records are viewable online through TRAK.
It is the responsibility of the Research Team to receive authorisation from XXX Ltd. eHealth Department prior to scanning any documents directly into
SCI Store and maintain a record in the Investigator Site File (ISF), verifying that documents have been uploaded correctly and is a true copy.
PROCEDURE
Required research information in the EPR
- The Investigator, or designee, will add an alert/research episode, as required, to the patient’s EPR to show they are taking part in a clinical trial of an investigational medicinal product.
- Information documented throughout a research study which is pertinent to a patient’s clinical care will be documented in their EPR by the Investigator, or designee. This will include eCasenotes scanned from paper case notes.
- Information will be recorded by the Investigator, or designee, in compliance with the study protocol and applicable regulatory requirements.
- Unless otherwise agreed with the trial Sponsor, information to be retained in the EPR should include the following where applicable to the study design;
- Copy of the signed consent form
- Details of consent process e.g. documenting the consent discussion
- Documentation of ongoing participant consent
- Copy of Participant Information Sheet
- Copy of GP letter/any correspondence to medical professionals
- Contact details for PI/research team
- Confirmation of participant eligibility
- Details of co-enrolment requirements for trial
- Details of IMP(s)/intervention(s) given (including batch numbers, date of dosing and dose received where applicable)
- Details required for emergency unblinding
- Details of any adverse events
- Details of concomitant medication
- Results and dates of any research specific procedures/tests
- Details of participant withdrawal or study discontinuation
- Date of participant study completion
- Any other information deemed relevant to clinical care by the Investigator
- The points on the above list which are required and the location that information is documented within the EPR will depend on many factors e.g. study design, specialty, and patient status at the time of the trial (e.g. inpatient or outpatient). The Investigator should agree a consistent approach with the research team on where the information will be documented for each participant within that trial and capture this record in the ISF (e.g. source data plan).
- This information listed in section 5.1.4 can be entered in the EPR in two ways:
1. Scanning of paper records to the EPR i.e. eCasenotes
- By dedicated eHealth Health Records scanning team
- Directly by research team after agreement with eHealth
2. Direct entry of data into TRAK e.g. as a clinical note
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Scanning by eHealth Health Records
- For any piece of information listed for which the source data is a paper record (e.g. patient consent document), the Investigator, or designee, should send a verified true copy (indicated by a dated signature following a visual check of the copy against the original) of the paper record to the Health Records department, in accordance with the XXX Ltd Records Scanning Policy.
- All documents sent for scanning must have a label placed on them containing the patient’s Community Health Index (CHI)/Unique Hospital Patient Identifier (UHPI). If no labels are available, the patient’s name, date of birth and CHI/UHPI should be clearly written on the document. The original source data must be filed in the Investigator Site File (ISF) or patient study folder by the Investigator, or designee. Where copies are taken from the original source data and retained in the ISF, these should also be marked as a verified true copy.
- Prior to sending the original/verified true copy of the record to the Health Records department, the Investigator, or designee, will detail the items to be scanned in an inventory and include this inventory when sending paper records for scanning. The inventory will be used for all records relating to a research only episode. Records included with inpatient or outpatient clinic notes will be sent according to local procedures. The Investigator, or designee, will retain a copy of the inventory to track documents sent to Health Records.
- This inventory will be completed by a member of staff at the Scanning Bureau in Health Records and returned to the Investigator, or designee, once all scanning is complete as per the XXX Healthcare Records Scanning Policy.
- On receipt of the completed inventory, the Investigator, or designee, will check the eCasenote to ensure all the records sent to Health Records have been scanned and are viewable online through TRAK. This check will be documented on the inventory. For regulated studies only (e.g. CTIMP or CIMD) the inventory must be maintained in the Investigator Site File (ISF) as a record verifying that documents have been uploaded correctly and are confirmed as a true copy.
- Information listed which does not have a specific paper record (e.g. PI contact details) can be typed directly into TRAK by the Investigator, or designee.
- When sending research documents to Health Records, the Investigator or designee should ensure they are sent separately from other scanning. Research documents should be secured with a treasury tag, and placed in a poly pocket with the above inventory and sent to Health Records marked:
- For Scanning – [insert site] Health Records.
- Category – Outpatient
- Specialty – [insert main specialty associated with research]
- Date of visit – [insert date of visit]”
Scanning by Research Staff
- If a research team wishes to scan documents directly into SCI Store, they must first have received authorisation from XXX eHealth Department. The authorisation will be for named members of the team to upload any document type as specified in the initial request. e.g. any Consent Form, PIS or GP letter relating to the study. The team are not required to seek authorisation for each separate study, just the document type.
- To request authorisation, the Investigator or the appropriate member of the research team must log a call with the eHealth Service Desk. To do this, click the e85050 icon on an XXX desktop/laptop and select Log a call, followed by SCI Store Upload from the TRAK section.
- The Investigator or member of the research team must complete the eHealth electronic request form and include details of the types of document that they wish to scan (e.g. Consent forms, Patient Information Leaflet, GP letter). Blank versions of each type of document must be attached to the call. These will be the only types of documents permitted to be scanned to patients’ SCI Store records by your team.
- Once the request has been authorised, instructions will be sent by XXX eHealth Department on uploading the documents and how to correctly file them within SCI Store.
- Where the Investigator or members of the research team are scanning documents directly into SCI Store, a record must be maintained in the Investigator Site File (ISF) by the person responsible, verifying that documents have been uploaded correctly and is a true copy.
- If in future there are additional documents (of a different type) to be scanned, these must be sent directly to the eHealth scanning team or a separate SCI Store upload request made for authorisation.
Inputting information directly to TRAK
- The Investigator or designee can add free text as a clinical note in the patient EPR tab on TRAK.
- For participants who are seen as an inpatient or in conjunction with a clinic visit, a clinical note will be added to that episode (EPR tab -> Overview/progress -> Clinical note -> add new) by the Investigator, or designee.
- For participants seen out with normal hospital visits, an appropriate patient episode may be required to attach the notes for the visit. This will allow clinical notes to be created in relation to the visit. The specialty will be listed as the department the participant visited (i.e. Clinical Research Facility).
- The Investigator, or designee, will create a new clinical note for each visit.
Key Information
- For all studies, information collected which pertains only to the research study and has no relevance to clinical care should be held and archived by the research team in the ISF or patient study folder and will not be sent for scanning to the EPR.
- Copies of case report forms will not be sent for scanning to the EPR, a summary of the visit will be captured either via direct entry into TRAK or on continuation sheets.
Including research documents with Clinical Scanning
To ensure documents are effectively stored, the preferred approach for scanning is to use Research Document Scanning Inventory. However, it is acknowledged that documents created as part of an outpatient/inpatient episode may be included with the clinical notes that are to be sent for scanning. Where including documents with other scanning, it is recommended all documents are clearly labelled and inform other staff involved in processing the notes of the requirement for these documents to be sent for scanning before they are dispatched to health records
REVISION HISTORY
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