Niche subcontractors are used increasingly for carrying out specific tasks of the sponsor, such as
monitoring, data management, Interactive voice response systems (IVRS), management of electronic
patient diaries or CRFs etc. In addition there are contractors who undertake tasks that are partly or
wholly related to the responsibilities of the investigator, even though the contractor may have their main
contract with, and be paid by, the sponsor (such tasks may include specialised testing, source data
retention (especially in the context of e-CRF or e-patient diary) or patient recruitment or follow-up
contacts).
This fragmented distribution of tasks could put additional strain on the maintenance of quality assurance
and compliance and obscure the clear responsibility and reporting lines for these tasks.
Great care is therefore needed in ensuring that the distribution of tasks is clearly documented and
agreed, that each party has the control and access to data and information that their legal
responsibilities require and that the ethics committees and regulatory authorities approving trials have
been properly informed of these activities as part of the clinical trial application process.
The legal framework:
The responsibility for the conduct of clinical trials is assigned, by Directive 2001/20/EC1, and by the note
for guidance on GCP (CPMP/ICH/135/952), to two entities – the sponsor and the investigator.
The roles of the sponsor, investigator, contract research organisation (CRO) and, monitor, are further
defined and described in Directive 2005/28/EC3 and in the glossary and chapters 4 and 5 of the note for
guidance on GCP (CPMP/ICH/135/95).
A number of the tasks involve access to, review, collection and/or analysis of data, much of it personal
data, and in specific cases contact with study subjects or potential study subjects. Data protection
legislation needs to be followed, in addition to the clinical trial legislation and guidance. Directive
95/46/EC4 sets out requirements for the protection of individuals with regard to the processing of
personal data and on the free movement of such data. The specific requirements foreseen by local
legislation, setting out the provisions for personal data protection, ethical review and informed consent,
should be followed.
Contracts and agreements
All the clinical trial related tasks are ultimately the responsibility of either the sponsor or the investigator.
Great care should be taken that the relative distribution of tasks to the different parties is well defined,
making clear the ultimate responsibilities in the context of each clinical trial. This should be carefully
documented, in the protocol, procedures, contracts or agreements and other documents.
The specifics of each particular clinical trial need to be taken into account when planning the trials,
during their conduct and monitoring and by audits or inspections.
This is particularly important where entering into novel arrangements that may arise, for instance in the
case of site management organisations (SMOs) or other organisations conducting tasks that relate to the
responsibilities of the investigator but where the organisation has its contract and funding with the
sponsor. These tasks can often involve contact with the study subjects.
The sponsor/CRO should determine the extent of monitoring of each party, within the context of GCP,
under particular circumstances. This should be justifiable, and ensure GCP compliance, in the context of
the clinical site organisation and the nature of the product and protocol being studied.
Contact with patients
Where direct contact with study subjects or their carers/guardians is involved, the privacy and
confidentiality of those involved and of any information maintained or collected needs to be respected in
compliance with the GCP and clinical trial requirements and with the personal data protection legislation.
Such contacts need to be considered in advance by the ethics committees concerned and be given a
positive opinion, either as part of the study specific opinion from the ethics committee or a more general
opinion in the context of subject screening procedures, which are not study specific.
Personal details such as identity or contact information should not be communicated outside of the
parties who have received the ethics committee approval and should not be used or communicated for
purposes other than those agreed by the ethics committee and consented to by the study subjects, and
where applicable, their carers or others who may be contacted and whose details might be retained.
