Beruflich Dokumente
Kultur Dokumente
SOP code
301
Version
18.6.2010
SOP name
Effective date
Authored by:
Approved by:
Version 3 / 18.6.2010
date:
date:
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Contents
1
2
3
4
Purpose..................................................................................................................................... 3
General..................................................................................................................................... 3
Responsibilities......................................................................................................................... 3
Monitoring Services................................................................................................................... 3
4.1
Monitoring plan and Evaluation of Monitoring Level..........................................................4
4.1.1 Level 1 Quality Control..................................................................................................4
4.1.2 Level 2 Monitoring........................................................................................................4
4.1.3 Level 3 Monitoring........................................................................................................5
5 Monitoring Visit Activities........................................................................................................... 5
5.1
Before a Monitoring Visit...................................................................................................5
5.2
At a Monitoring Visit.......................................................................................................... 5
5.2.1 Study Progress............................................................................................................. 5
5.2.2 Investigators Trial File..................................................................................................5
5.2.3 Investigator Qualifications, Resources and Facilities....................................................6
5.2.4 Compliance with Protocol, ICH GCP and Regulatory Requirements.............................6
5.2.5 Informed Consent.........................................................................................................6
5.2.6 Case Report Forms and Source Documentation...........................................................6
5.2.7 (Serious) Adverse Events.............................................................................................6
5.2.8 Investigational Medicinal Product..................................................................................6
5.2.9 Biological samples........................................................................................................7
5.3
After a Monitoring Visit......................................................................................................7
6 Appendices............................................................................................................................... 7
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1 Purpose
The purpose of this SOP is to describe the principles of the monitoring services provided by The
Unit and the monitoring procedures in clinical studies monitored by The Unit. The operating
procedure has been developed in collaboration with the Finnish University Hospital research units
and aims to harmonise monitoring procedures regardless of location. Each research unit may,
however, define additional specific administrative in-house procedures in order to comply with
hospital administration. The responsibility for maintaining this operating procedure lies with named
representatives of the research units.
2 General
This SOP applies to all investigator-initiated clinical studies on medicinal products monitored by
The Unit unless otherwise agreed with the Principal Investigator.
Clinical studies are monitored in order to ensure that:
- the rights and well-being of the human subjects participating in the study are protected
- the study is conducted in compliance with the approved study protocol (and its
amendments, if applicable), with ICH-GCP (if applicable) and with other relevant regulatory
requirements
- the reported data are accurate, complete and verifiable from source documents.
According to the regulation 1/2007 on Clinical Trials on Medicinal Products in Human Subjects the
general prerequisites for clinical trials on medicinal products include the requirement that the trial
must be conducted in accordance with the principles of good clinical practice and the principles of
the Declaration of Helsinki and thereby that the necessary procedures to secure the quality of
every aspect of the trial shall be complied with.
3 Responsibilities
The Principal Investigator is responsible for complying with procedures necessary to secure the
quality of every aspect of the trial. The Principal Investigator is responsible for determining the level
of monitoring and for enabling monitoring activities at the study site.
The Study Monitor is responsible for conducting the monitoring visit in accordance with the
Monitoring Plan, this SOP (unless otherwise agreed) and regulatory requirements.
4 Monitoring Services
Monitoring services are provided by The Unit mainly for investigator-initiated studies on medicinal
products. For other types of clinical studies, monitoring services may be provided when considered
necessary.
In order to increase the awareness of the quality requirements the in-house organizational
approval form should identify monitoring as a potential service to be agreed on. In association to
handling of the approval forms, monitoring services should actively be offered to investigators
conducting investigator initiated studies on medicinal products. Specific attention should also be
paid to organizational approval for in-house monitoring to take place, as well as to the fact that the
subject information includes appropriate information about the monitoring process.
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Safety profile of the investigational product and thereby the safety of the study subjects
Extent of intervention
Recruitment rate
Complexity of study design and organization
Study site and study personnel
Resources
The level of monitoring can be evaluated by using the appended chart (Appendix 1) for guidance.
The organization has defined three different levels of monitoring, i.e. level 1 quality control, level 2
monitoring and level 3 ICH GCP monitoring.
Existence of signed Informed Consent Forms and verification of the existence of the
subjects
Existence and maintenance of an Investigators Trial File and
The use of Case Report Forms
The level 1 quality control activities shall be documented in the Monitoring Visit Report. Obvious
shortcomings shall be communicated to the Investigator and corrective activities agreed upon.
Informed consents
The Investigators Trial File
Serious adverse events
Investigational products, as appropriate
Reasons for withdrawal and study termination
A study initiation and study completion visit
Monitoring visit frequency defined separately for each study (e.g. first visit as soon as
possible after inclusion of subjects and at least two annual visits during the recruitment
period)
Inclusion- and exclusion criteria
Main parameters
Source data verification (SDV) defined separately for each study, e.g.:
o 100% SDV for the first two subjects and then e.g.:
o 100% SDV for a separately defined number of subjects
o a separately defined set of data for 100% of the subjects or
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100% SDV for a separately defined number of subjects and then a separately
defined set of the data for the remaining subjects (randomization procedures to be
defined).
The level 2 monitoring activities shall be documented in the Monitoring Visit Report.
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6 Appendices
Appendix 1 Extent of monitoring -chart
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Date
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