13 Principles of GCP

1. Clinical Trials should be conducted in accordance with ethical principles of the

Declaration of Helsinki

2. Before initiation, risks and inconveniences should be weighed against

anticipated benefit

3. The rights, safety and wellbeing of trial participants must prevail over science
and society

4. Available information on an Investigational Medicinal Product should

adequately support proposed clinical trial

5. Clinical trials should be scientifically sound, and described in a clear, detailed

protocol

The Investigator and the Research Governance and Integrity Office (RGIO) at
LSHTM ensure that all of the above are in place prior to approval being granted for
the Clinical Trial. Any research conducted by Staff and Students must be
submitted to the RGIO for Sponsorship review and to the relevant LSHTM Ethics
Committee
13 Principles of GCP
6. A trial should be conducted in compliance with the protocol that has received favourable ethics approval
- Obtain Institutional Review Board/Independent Ethics Committee approval
- Research team should be familiar with Protocol
- Attend any trial specific training provided

7. The medical care and medical decisions made on behalf of participants should always be the
responsibility of qualified physician
- Completion of all trial delegation logs you are involved with. The CI and PI have overall responsibility
for medical care however, these duties can be delegated to others and this needs to be documented and
signed off by the CI/PI efficiently

8. Each individual involved in conducting a trial should be qualified by education, training and experience
to perform their tasks
- Complete GCP course
- Read the Core Standard Operating Procedures
- Attend any trial specific training provided

9. Freely given Informed Consent should be obtained from every participant prior to clinical trial
participation
- Read Informed Consent SOP
- Clearly document consent process in medical notes
13 Principles of GCP
10. All Clinical Trial Information should be recorded, handled and stored appropriately
- Ensure all trial related investigations are performed
- Clearly document all information in medical notes

11. The Confidentiality of records that could identify participants should be protected
- Anonymise/Pseudo anonymise data?
- Informed Consent Process – sharing of information with third parties

12. Investigational products should be manufactured, handled, stored in accordance

with GMP and approved protocol
- System to document shipment, receipt, disposition, return, destruction of IMP

13. Systems with procedures that assure the quality of every aspect of the trial
should be implemented
- Delivering high quality research brings with it many challenges.
- Commitment at every level of the organisation to deliver the ‘extra’ that is required.
- Development of systems and procedures to ensure that research is conducted to the highest
standards