WP 02: Data platform

Objectives

  1. Develop and maintain an online randomisation and eCRF service.        (Tasks 1,2)
  2. Act as a data hub, receiving data from eCRF and adjudicators and serving data to other WPs to support their activities. (Tasks 3-7)
  3. Provide a data platform for sub-studies and for non-EU participants.     (Task 8)

Work package Description

This WP will be led by Bridget Colam (UEDIN), an experienced trial co-ordinator who managed and co-ordinated the GALA trial (a multicentre trial of general versus local anaesthetic for carotid endarterectomy, which recruited3526 patients from 95 centres in 24 countries). The randomisation service and eCRF will be developed and maintained by David Perry and colleagues, a clinical trial IT group with substantial relevant experience. It will be based on the randomisation service developed for the Edinburgh Hypothermia Acute Ischaemic Stroke pilot study. Help and assistance (both embedded within the eCRF and available by email/telephone) will be available to users.

Task 1: Randomisation platform (M01-48). This will be web based, and conducted according to an algorithm designed to deliver the stratifications called for in the study protocol. The process of randomisation will also calculate the volume of cooled saline to be given (based on the body weight provided) and will initiate a unique CRF record for that patient. The randomisation service will be available 24 hours per day seven days per week. Performance of the system (including delivery of balanced groups) will be reviewed at least annually, so that any changes required might be made.

Task 2: eCRF (M01-60). Completion of randomisation will provoke the initiation of an eCRF record for that patient held in a secure SQL Database server which includes access control; audit logs; daily back-up; and HTTPS/SSL encryption. Case Report Form data fields as laid out in the Study Protocol can be completed online in real time. Other types of data required for all subjects (e.g. CT or MR images, digital video) or only those in sub-studies (perhaps data logged from cooling devices, or CT perfusion data) can also be uploaded, stored and served to other investigators for analysis or adjudication.

Task 3: Data completion (M06-56): The eCRF will include algorithms to issue automated reminders for data completion. Where data remain incomplete the data resolution team will contact the local site directly. In addition to the automatic algorithms, the following measures will be taken in order to achieve a high level of accuracy in the data entries: (1) the eCRF will be introduced in the training program (WP 6) and the most relevant aspects and details will be covered both in the eLearning module and the class-room training; (2) a certain percentage of the total compensation paid to the participating units will be linked to the data accuracy; in other words the centres will get the full payment (or a quality premium) only if they provide complete and accurate data; (3) the Clinical Monitors will be made aware of in case a centre does not perform at adequate standards, and will be able to address the issues during monitoring visits.

Task 4: Central Statistical Monitoring (M06-48): The eCRF office will receive faxed copies of every, fully signed patient consent form. The eCRF will include algorithms to identify implausible data values, and to identify centres with high error or revision rates. This Central Statistical Monitoring will inform the frequency of On Site Monitoring visits. In addition to the impact on the On Site Monitoring visits there might be a decision to re-train the staff working on the trial, especially considering the data entry personnel.

Task 5: Support for SAE reporting (M06-48): The eCRF will provide online forms for Serious Adverse Event reporting. When a form is completed it will be notified immediately to the Central SAE adjudication committee. Where further information is required the data manager will contact the recruiting centre. Besides enabling the initiation of the SAE reporting, the system will also allow to record and store the relevant documentation –including for example the decision by the Central SAE Adjudication Committee. All functionalities of the system will be fully tested during the user acceptance test.

Task 6: Support for training WP: signal for the initiation of the coaching process (M06-40): When a patient is randomised (WP6, Training) the responsible colleagues will be informed by email and SMS, in order that the site may be contacted and mentoring offered (for more details, see WP6).

Task 7: Data archiving (M01-240): all materials will be archived for at least 15 years from the date of completion of the study. The archiving system will be compliant with the relevant requirements and standards. The archiving system will be fully described in the eCRF testing report.

Task 8: Sub studies (M12-60). These will be supported as they arise, including additions to the eCRF if these are required. Considering the important international interest in the EuroHYP-1 trial, it is possible that sub-studies will be initiated, based on grant received from other countries.

Task 9: Performance reports (M9-55). Generate quarterly (as of Month 10) an online summary report highlighting the key data and performance quality indicators. The performance indicators will be defined jointly by the Executive and Steering Committees, and would also serve as a basis for the implementation of the Monitoring plan and actions.

Participating Partners

University of Edinburgh

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