C

• Chief Investigator (CI)

  The Investigator with overall responsibility for the research, who is accountable to their employer, and through them to the sponsor. In a multi-site study the CI has responsibility for design, management and reporting of the study, coordinating investigators who take the lead at each site.

  All applications for ethical review should be submitted by the CI.

   

• Child

  There are different and confusing definitions of ‘child’ that affect consent issues in medical research. The situation is best explained in the Children station in the Data and Tissues Tool Kit.

   

• Clinical trial

  With the advent of the Clinical Trial Regulations, the term clinical trial is used to describe a trial that tests the safety or efficacy of an investigational medicinal product, i.e. a clinical trial that is within the scope of the UK Medicines for Human Use (Clinical Trials) Regulations 2004. To avoid confusion we recommend that the term Clinical Trials Of an Investigation Medicinal Product or CTIMP is used for this definition.

  In the academic sector the term clinical trial is commonly used more loosely to describe:

  Any prospective evaluation of a health care intervention, which involves the administration of a treatment or type of management, including diagnosis or the provision of lifestyle (e.g. dietary) advice.

   

• Clinical Trial of an Investigational Medicinal Product (CTIMP)

  A clinical trial that is within the scope of the UK Medicines for Human Use (Clinical Trials) Regulations 2004, i.e. a trial that tests the safety or efficacy of an investigational medicinal product. For more information, please see Is the trial within the scope of the UK Regulations? station in the Clinical Trials Tool Kit.

   

• Clinical Trial Regulations

  The Medicines for Human Use (Clinical Trials) Regulations (2004) is the law within the UK that applies to research into the safety and/or efficacy of investigational medicinal products. These Regulations are how the EU Clinical Trials Directive was transposed into UK legislation. Further information can be found in the Clinical Trials Tool Kit.

   

• Coded

  Coded samples or data have a coded identification to protect the confidentiality of the individual during routine use, but it is possible for the code to be broken, and thus identify the individual from whom they were obtained. The key should not be freely accessible but held by senior individuals with a strict duty of confidentiality.

   

• Competence

  The ability of a person, given the necessary information, to understand the nature and the consequences of the proposed procedure or treatment, and to use that information to make a valid choice in accordance with their own fundamental values.

  In relation to research this would be the ability to understand the research project and their proposed role with in that project. And to make a decision as to whether they would like to participate or not, based on this information.

   

• Confidential information

  Any information obtained by a person on the understanding that they will not disclose it to others, or obtained in circumstances where it is expected that they will not disclose it. The law assumes that whenever people give personal information to health professionals caring for them, it is confidential as long as it remains personally identifiable. See also 'Personal data'.

   

• Confidentiality

  The duty of persons to whom personal information has been given not to share the information with any unauthorised person.

   

• Consent

  The voluntary agreement of an adult or competent child to participate in research, based on adequate knowledge and understanding of the relevant information.

  Consent is often recorded by a signature on a consent form, but is simply a record of the dialogue and thought which has taken place. Consent can be verbal, the person seeking consent should record this.

   

• Consent form

  A written record of the study participant’s decision to take part in the research study.

   

• Custodian

  The custodian is responsible for the safekeeping of data or tissue samples and control of their use, and eventual disposal (if required), all in accordance with legislation and the terms of the consent given by the donor.

  Custodianship implies some rights to decide how the data/samples are used and by whom, and also responsibility for safeguarding the interests of the donors.