1. Title page
The title page of a clinical study report tells a reader which study the report describes, what treatment it investigates, who is responsible for it, and which of the study’s reports it is. Section 1 of ICH E3 lists fourteen items for it, from the study title to the report date, and they rest on terms such as investigational product, indication, sponsor, protocol, development phase, investigator and Good Clinical Practice.
What the title page tells the reader
The title page answers four questions: Which study is this? What treatment does it investigate? Who is responsible? Which report am I reading? It gives the reader enough information to recognise the trial before entering its methods and results.
A clinical study report (CSR) is the detailed account of an individual clinical study, and ICH E3 is the guideline that describes its structure and content. The title page identifies that account. A study can produce more than one report, and a treatment can appear in many studies, so the product name, study identifier, and report date each do a different job.
Section 1 of ICH E3 lists fourteen items.
1. Study title
The study title is the formal name of the trial. It usually tells the reader what is being investigated and in whom. It can also describe how the comparison works.
For example: A randomised, double-blind, placebo-controlled study of ABC-123 in adults with hypertension.
The specialist words in this example describe the study design. The title should identify the study accurately, but it does not need to tell the entire scientific story.
2. Name of the test drug or investigational product
The investigational product is the product being evaluated. ICH E6(R3) defines it as a pharmaceutical form of an active ingredient or a placebo, being tested or used as a reference in a clinical trial. A medicine in development can have a code such as ABC-123 before it has a widely used name. An existing medicine can also be investigated, for example in a different condition.
The product name answers “What is being studied?” The protocol identifier, introduced below, answers “Which particular study of that product?”
3. Indication studied
The indication is the disease or condition for which the product is being investigated. It can include a particular severity or treatment setting.
For example: Hypertension.
The indication and participant population are related but different. The indication identifies the medical use. The population adds details about the people in the study, such as adults whose symptoms remain uncontrolled despite their existing treatment.
“Indication studied” does not assert that the product is approved for that use.
4. Brief description of the study
If the title does not make the relevant information apparent, E3 asks for one or two sentences covering design, comparison, duration, dose, and patient population.
The study design describes how the investigation is organised. The following terms can make a short description carry substantial information:
| Term | Meaning in ordinary language |
|---|---|
| Parallel-group | Participants receive their assigned treatment in separate groups during the comparison period. |
| Cross-over | Participants receive different treatments in successive periods. |
| Randomised | A chance-based process assigns participants to treatment groups. |
| Blinding | Specified people are kept unaware of treatment assignments. |
| Placebo comparison | The comparison uses a preparation without the active treatment being investigated. |
| Active comparison | The comparison uses another active treatment. |
| Dose–response comparison | Different dose levels help show how effects change with dose. |
A dose is the amount given on an occasion. The description can also state how often the dose is taken. Duration tells the reader how long the relevant treatment or observation lasts. The population identifies the defining characteristics of the participants.
For example: Adults with uncontrolled hypertension receive ABC-123 10 mg or placebo orally once daily for 12 weeks in a randomised, double-blind, parallel-group study.
“Orally” means by mouth. “Double-blind” is a shorthand label for concealed treatment assignments. The detailed methods must identify exactly which roles are blinded; the label alone is insufficient. This compact description introduces the design without replacing the full explanation of how the study works.
5. Name of the sponsor
The sponsor is the person or organisation responsible for initiating and managing the trial and arranging its financing, and ICH E6(R3) defines the role in the same terms. It is often a pharmaceutical or biotechnology company, but sponsorship is not limited to companies.
An outside organisation can carry out study work without becoming the sponsor. The title page identifies the sponsor; the administrative structure elsewhere in the report explains the other organisations and responsibilities.
6. Protocol identification: code or number
The protocol is the document that sets out the study’s plan: its purpose, design, procedures, and planned analyses. ICH E6(R3) defines it as the document that describes a trial’s objectives, design, methodology, statistical considerations and organisation. Its identifier distinguishes the study from others.
For example: ABC-123-003.
The code is useful because the same product can have several similar-looking studies, and it connects the report to the correct protocol and supporting study documents. The number itself does not establish a study’s phase or design unless the sponsor’s numbering system explicitly says so.
7. Development phase
The development phase places the trial within the broader investigation of the medicine. The familiar phase labels provide orientation:
| Phase | Broad purpose |
|---|---|
| Phase I | Initial investigation of matters such as tolerability, safety, and what happens to the medicine in the body. |
| Phase II | Exploration of benefit and dose in the condition being treated. |
| Phase III | Confirmation of benefit and further characterisation of safety for the intended use. |
| Phase IV | Investigation after approval. |
These descriptions are broad. A study can combine phases, and its actual objectives provide more detail than the phase label alone. E3 requires the phase to be identified on the title page; it does not require a tutorial on the development programme there.
8. Study initiation date
The initiation date records when the study begins. E3 gives first patient enrolled as an example and permits another verifiable definition.
“Verifiable” means that the event and date can be established from study records. A date without its meaning can mislead: first consent, enrolment, and first treatment are potentially different milestones. The report states which definition it uses.
9. Date of early study termination, if any
The early termination date applies when the study ends before its planned completion. The title page records the date; the report explains the circumstances in the relevant sections.
Early termination is a study-level event. One participant leaving early does not mean that the entire study terminates early.
Early termination can arise from safety concerns, recruitment difficulties, or other reasons. The date alone does not tell the reader why the study stops or what its results mean.
10. Study completion date
E3 describes the completion date as last patient completed. It establishes the end of participant activity under the applicable completion definition.
The final dose and the final follow-up visit can fall on different dates. If follow-up continues after treatment, the last dose does not necessarily mark study completion.
Three dates therefore need to be kept distinct:
| Milestone | What ends or occurs |
|---|---|
| End of treatment | Administration of the planned treatment ends. |
| Study completion | The last participant completes the applicable study activities. |
| Report date | This report is issued. |
The study can finish before the report is ready because the data still require preparation, analysis, interpretation, and review.
11. Investigator or responsible medical officer: name and affiliation
E3 asks for the name and affiliation of the principal or coordinating investigator or investigators, or the sponsor’s responsible medical officer.
An investigator is responsible for conducting the trial at a study location. Where a team conducts it, the principal investigator leads that team. ICH E6(R3) defines the investigator by the same responsibility for the trial’s conduct. A coordinating investigator coordinates investigators across participating locations. The sponsor’s responsible medical officer is the relevant medical representative on the sponsor side.
These roles are alternative ways of identifying relevant medical responsibility on the title page, and the item does not require the complete list of everyone who works on the study.
Affiliation means the institution or organisation with which a person is associated: for example, Dr Jane Smith, University Hospital.
12. Company or sponsor signatory and review contacts
The signatory is the person responsible for the study report within the company or sponsor. E3 asks for that person’s name.
E3 also asks for the name, telephone number, and fax number of company or sponsor contacts who can answer questions during review. Those contact details can appear on the title page or in the application letter. Fax is part of E3’s stated wording; the underlying purpose is to identify a reachable review contact.
The person who drafts the report and the person responsible for signing it need not be the same.
13. Statement about Good Clinical Practice, including archiving
Good Clinical Practice (GCP) is the ethical and scientific framework for conducting and reporting clinical trials. Its central concerns include the rights, safety, and well-being of participants and the reliability of the information produced.
E3 asks for a statement indicating whether the study follows GCP, including the archiving of essential documents. The wording reports actual compliance; it is not an automatic declaration to copy without checking.
Archiving means retaining the study records in an organised, retrievable form. Essential documents are the records needed to evaluate how the trial is conducted and the quality of the information it produces. Keeping the final CSR alone does not fulfil that purpose.
GCP extends across the design, conduct, recording, and reporting of a trial, and its recording and reporting include the management and archiving of study files, which helps explain why the title-page statement reaches beyond the quality of the prose in the report. ICH E6(R3) defines GCP as a standard for the planning, initiating, performing, recording, oversight, evaluation, analysis, and reporting of clinical trials. It describes essential records as the documents and data that collectively allow the methods used, the factors affecting a trial and the actions taken during its conduct to be evaluated, to determine the reliability of the trial results and verify that the trial was conducted in accordance with GCP and applicable regulatory requirements.
The title page states the position briefly. The body and supporting records provide the detail needed to assess it.
14. Report date and identification of earlier reports
The report date identifies the particular document being read. E3 also asks that earlier reports from the same study be identified by title and date.
For example, an interim report presents information available before the final report. Identifying both makes their relationship visible. Interim means prepared at an intermediate point rather than after all intended study information is available.
The study identifier stays connected to the trial, while report titles and dates distinguish its reports. Together with the product and sponsor names, they make the document traceable to the right study and the right account of that study.