A multicenter, randomized phase III study of bortezomib and ...

HOVON 104 AL AMYLOIDOSIS Clinical trial protocol version 7, 27 November 2012
Reason for end of protocol treatment.
Each CRF page will be identified by a pre-printed trial number, and a combination of patient study
number (assigned at registration), hospital name to be filled out before completing the form.
The CRF will be completed on site by the local investigator or an authorized staff member. Each page
must be dated and signed by the local investigator upon completion. All CRF entries must be based
on source documents. The CRF and written instructions for completing the CRF will be provided by
the HOVON Data Center.
Copies of the CRF will be kept on site. The original CRF pages must be sent to the HOVON Data
Center at the requested time points. How and when to send in forms is described in detail in the CRF
header and the CRF instructions.
All data from the CRF will be entered into the study database by the HOVON Data Center.
Country specific addition for GERMANY:
On the study specific case report forms the complete birth date will be asked for. In Germany only the
entry of the year of birth is allowed according to data protection. Therefore spaces for day and month
on the CRF-pages will be crossed out and only the year will be entered.
16.2 Data quality assurance
Steps to be taken to ensure the accuracy and reliability of data include the selection of qualified
investigators and appropriate study centers, review of protocol procedures with the investigator before
the study, and site visits by the sponsor.
Data collected on the CRF will be verified for accuracy. If necessary, queries will be sent to the
investigational site to clarify the data on the CRF. The investigator should answer data queries within
the specified time line.
16.3 Monitoring
The sponsor will perform on-site monitoring visits to verify that the rights and well-being of patients
are protected, the reported trial data are accurate, complete, and verifiable from source documents
and the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with
GCP, and with the applicable regulatory requirement(s). Monitoring visits will take place according to
the study specific monitoring plan.
Direct access to source documentation (medical records) must be allowed for the purpose of verifying
that the data recorded in the CRF are consistent with the original source data. The sponsor expects
that during monitoring visits the relevant investigational staff will be available, the source
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