3. Table of contents
A clinical study report’s table of contents locates two kinds of material: the report’s own sections with their summary tables, figures and graphs, and the appendices, tabulations and any case report forms provided to support the main account. What serves as locating information other than a page number turns on the report’s format.
What Section 3 asks for
The table of contents, often shortened to TOC, is the report’s navigation list. Section 3 helps readers find their way around the report and its supporting material. For example, a reader may want to check why participants leave a study and then examine the individual records behind that summary, and a useful table of contents makes both destinations easy to find.
Section 3 sets two requirements. The table of contents should include:
- the page number or other locating information of each section, including summary tables, figures and graphs;
- a list and the locations of appendices, tabulations and any case report forms provided.
Navigation serves comprehension. Excessive movement between text and distant supporting tables can make a report harder to understand. A working link helps readers reach evidence, but the surrounding text still needs enough information to explain its significance.
Finding the report’s sections and displays
A heading tells the reader what a section covers, and its locator tells them where to go.
Summary tables, figures and graphs are different ways of presenting information:
| Item | What it contains | Example |
|---|---|---|
| Summary table | Information condensed into rows and columns | Numbers of participants who complete or leave the study |
| Figure | A visual explanation or display | A diagram showing the study’s treatment periods |
| Graph | A figure showing numerical patterns | A line chart showing a measurement over time |
So a table of contents reaches beyond a list of chapter titles: readers also need a route to the displays containing the evidence they want to inspect. Section 3 does not prescribe the exact layout; separate lists of tables and figures are one practical way to organise that navigation.
Finding the supporting material
The second requirement covers material that supports the main account:
- Appendices are supplementary sections containing documents or detailed information, such as the study protocol.
- Tabulations organise data into tables. They may provide more detail than the selected summaries beside the main discussion.
- Case report forms (CRFs) are forms used to record study information for individual participants. Section 3 asks for the locations of any such forms provided; it does not itself decide which forms must be included.
A listing presents detailed records, often arranged by participant. For example, a summary table gives the number of people who stop treatment, while a participant listing gives each person’s recorded reason. Later sections specify the supporting documents and listings relevant to each topic.
The need for these separate destinations follows from the report’s structure. A clinical study report has several components: the main text, the Section 14 outputs and the Section 16 appendices. Electronic assembly connects these components into a report that a reviewer can navigate. This structure and its electronic assembly are not an additional Section 3 requirement.
What “other locating information” means
A page number works well when material shares a clear pagination system. If supporting documents occupy separate files, “page 12” alone can be ambiguous. A document identifier, a section identifier and a working link can make the destination clear, and the exact implementation depends on the report’s format.
A hyperlink is a clickable route to another location. A cross-reference is a pointer within the text, such as “see Appendix 16.2.1”, and it can also be a hyperlink. Both support navigation, while the table of contents provides the overall map.
For example, an illustrative set of entries might identify:
| Entry | Destination |
|---|---|
| 10.1 Disposition of patients | The report section explaining participant flow |
| Figure 10.1 Participant flow | The diagram showing movement through the study |
| Appendix 16.2.1 Discontinued patients | The detailed participant listing |
The section heading, display title and appendix label should match their destinations. Checking that page numbers and links still resolve after assembly is a practical quality check. Contents, indexes and hyperlinking are among the skills involved in preparing quality documents.