6. Investigators and study administrative structure
Section 6 of a clinical study report under ICH E3 sets out who carried out the study and who answers for the report. It has three parts: a brief description of the study's administrative structure in the body of the report, a list of the investigators and other important participants with their roles and qualifications in Appendix 16.1.4, and the signatures in Appendix 16.1.5.
What Section 6 asks for
Section 6 explains who does the work, which organisations take part, and who takes responsibility for the report. In everyday terms, it is the study’s map of people and responsibilities.
In a trial conducted in several hospitals, doctors and nurses see participants, a laboratory tests samples, a statistics team analyses the results, and a medical writer develops the report with input from the study team. A short list of hospital names does not explain this arrangement. Section 6 connects people and organisations with their actual roles.
The section has no numbered subsections. Its requirements fall into three parts:
| Everyday question | Where the information belongs |
|---|---|
| How is the study organised? | A brief description in Section 6 |
| Who carries out the important work, and what qualifies them? | Appendix 16.1.4 |
| Who signs to confirm the report’s account? | Appendix 16.1.5 |
Administrative structure
The investigators named on the title page sit within a wider organisation, and the synopsis identifies the study centres. A multicentre study follows one common protocol across several centres.
E3 asks for a brief description of the study’s administrative structure: the arrangement of people, committees, institutions, and services through which the study operates. Administrative here covers important scientific and medical responsibilities as well as day-to-day coordination.
E3 gives the following roles and organisations as examples of relevant functions. It does not require every study to establish every listed role or committee.
| Role or organisation | Plain-language explanation |
|---|---|
| Principal investigator | The investigator who leads a site, with the responsibilities assigned to that role |
| Coordinating investigator | The investigator whose remit is coordination across centres |
| Steering committee | A group that provides overall direction and oversight according to its assigned remit |
| Administration | The people or organisation coordinating operational work, such as schedules, study records, and communication |
| Monitoring committees | Groups that review aspects of the study as it proceeds; their precise remit needs to be stated |
| Evaluation committees | Groups that assess specified study information or outcomes using defined criteria |
| Institutions | Participating organisations, such as hospitals, universities, and research centres |
| Statistician | The specialist responsible for relevant statistical planning, analysis, and interpretation |
| Central laboratory facilities | A laboratory service receiving and analysing study samples from participating sites |
| Contract research organisation (CRO) | An external organisation engaged to perform specified study-related work |
| Clinical trial supply management | The function organising the provision and handling of study treatment supplies |
The same job title can cover different tasks in different organisations. The useful question is what the person does in this study.
The report needs to describe the actual division of work. “A CRO supports the study” leaves open whether that support covers site operations, data processing, statistics, writing, or several functions.
Committee titles also need context. One committee may review accumulating safety information while another assesses whether reported events meet the study’s outcome definition, and the reader should be able to tell their purposes apart. Section 6 does not, by itself, require every study to have an independent monitoring committee.
A description of a fictional study might read:
The study operates at six hospital sites, each led by a principal investigator. A coordinating investigator supports coordination across sites. North Research Services manages site monitoring and study data processing. Central Lab A performs laboratory testing. The sponsor’s statistics team analyses the data, and the medical writing team prepares the report with clinical and statistical input. Appendix 16.1.4 provides the personnel and qualification details.
A short table is another practical way to present the structure; E3 asks for a brief description without prescribing this particular format.
Appendix 16.1.4: people, roles, and qualifications
E3 asks for a list of the investigators that gives each one’s:
- Affiliation: the organisational identity given in Section 1.
- Role in the study: the work or responsibility the person holds.
- Qualifications: relevant education, training, and experience, documented through a curriculum vitae or an equivalent account.
A curriculum vitae (CV) records a person’s professional background. Appendix 16.1.4 calls for brief, one-page CVs or equivalent summaries of training and experience relevant to carrying out the study. The E3 questions and answers clarify that the investigator and site list supports review, while CVs generally remain in the underlying study files unless they are needed or required for submission.
A fictional record could identify “Dr A. Example, Central Hospital, principal investigator,” followed by a brief account of relevant clinical training and research experience. The name identifies the person, the role connects them to the study, and the qualifications help establish their preparation for that work.
The appendix also gives a similar list for other people whose participation materially affects the conduct of the study, materially meaning in a meaningful or consequential way.
E3 names three groups for the listing:
- Investigators: the people conducting the investigation at the participating sites.
- Other people making observations of the primary or other major efficacy variables: the people responsible for measuring important treatment outcomes.
- The report’s authors, including the responsible biostatisticians: the people who contribute the report and its statistical account.
The efficacy measurements given in Section 2, such as a symptom score, determine which observations are central to the study.
The list extends beyond doctors: E3’s examples include nurses, physician assistants, clinical psychologists, clinical pharmacists, and house staff physicians, who are doctors in hospital training posts. A clinical psychologist who regularly administers the study’s central assessment, for example, can have a direct effect on its key measurements.
E3 does not require the list to include people with only an occasional role, such as an on-call physician dealing with a possible adverse effect or a temporary substitute for one of the listed staff. This is a boundary for the CSR listing; it does not say that occasional clinical care is unimportant or that its underlying records disappear.
Report authors and biostatisticians
A biostatistician applies statistical methods to biological and medical data, and that contribution can start with study design and continue through analysis and interpretation. Section 6 expressly includes the responsible biostatisticians among the report authors in the listing.
The medical writer’s contribution is distinct from conducting clinical visits. A writer can develop the report by assembling and explaining study evidence, with input and review from the team.
Abbreviated listing for large studies
For large trials with many investigators, E3 allows an abbreviated listing: general statements of qualifications for particular roles, with each investigator’s or other relevant person’s:
- Name.
- Degree.
- Institutional affiliation.
- Study role.
The appendix can, for example, describe the qualifications of the investigators as a group, then give a table identifying each investigator with their institution and role. The flexibility concerns how qualification information is presented; it does not turn the list into an anonymous description of “experienced staff.”
Appendix 16.1.5: signatures
Appendix 16.1.5 identifies the signatures supporting the report, and the distinction between authors and signatories drawn in Section 1 applies to it.
E3’s wording is conditional:
- Where regulatory authorities require the principal or coordinating investigators’ signatures, those signatures appear in Appendix 16.1.5.
- Where those signatures are not required, the sponsor’s responsible medical officer signs in Appendix 16.1.5.
The applicable authority’s requirements decide whether investigators sign, and the sponsor’s responsible medical officer is the alternative E3 specifies. Section 6 does not establish a universal rule that every investigator and every report author signs.
Annex II of E3 provides an example signature form. It identifies the study and its authors, then asks the signatory to confirm that they have read the report and that, to the best of their knowledge, it accurately describes the study’s conduct and results. The form also has space for affiliation and date.
That confirmation concerns the accuracy of the study account, whether the investigator or the sponsor’s medical officer signs. It does not declare that the treatment succeeds or has no risks. A report with disappointing results still needs an accurate description and the appropriate signature.
The study authors that the Annex II form names are not necessarily the report’s signatories, and E3 does not clearly specify the distinction, if any, between the form’s study authors and the report authors that Section 6 lists.
Where to look
| Location | What it provides |
|---|---|
| Section 6 | A brief account of the study’s people, organisations, and responsibilities |
| Appendix 16.1.4 | Investigators, other important contributors, report authors and responsible biostatisticians, with roles, affiliations, and relevant qualifications |
| Appendix 16.1.5 | The applicable investigator or sponsor medical officer signatures |
| Annex II | An example signature form in the guideline |
Section 6 makes the people behind the evidence identifiable, so the later methods and results can be read with a clear understanding of who performs the work and who confirms the report’s account.