Trial registration

All research should be registered in a publicly accessible database and many funders expect all researchers, research sponsors, and others to meet this fundamental best practice standard. For clinical trials, it is a condition of a favourable ethical opinion to do so. For all other studies, it is a good practice expectation. [HRA Research registration and research project identifiers].

Your protocol will form the basis of the information you are required to enter to register your trial.

ClinicalTrials.gov run by the United States National Library of Medicine (NLM) was the first online registry for clinical trials and is the largest and most widely used today.

Similar clinical trial databases now exist all over the world: The WHO’s trial registry is globally applicable. African trials can be registered in the Pan African Clinical Trial Registry (PACTR), Australia and New Zealand share the same clinical trial registry, known as the Australia and New Zealand Clinical Trial Registry (ANZCTR). Clinical Trial registry exists in other countries such as India, China, Brazil, Sri Lanka, Japan etc.

An introduction to the 'study walk-through' method:

The study walk-through is a method to ensure that every step in a study protocol is carefully considered in its operational context and that those responsible for undertaking the step are tasked with overseeing it appropriately.

  1. The entire study team is gathered as early as possible in the planning of the study
  2. An overview of the study protocol is presented, focusing on the primary endpoints and how these will be measured.
  3. One team member then leads the process of describing the study step-by-step, as it would be operated at the study centres.
  4. Each team member is encouraged to imagine each step from the participant’s perspective.
  5. The process covers steps from community engagement and recruitment, through each visit, until the end of the study.
  6. The processes and data collected are discussed in the context of actions that relate specifically to the patients, e.g. clinical assessments.
  7. The coordinator leads the discussion of each study step, which is recorded as the discussion flows.

Standard Operating Procedures (SOPs)

SOPs translate the protocol into the real steps and activities needed to run the study in the specific setting where it is to be undertaken. Therefore, SOPs need to be developed by all those in the study team who will be tasked with delivering each of these steps. SOPs should never be written remotely by a distant sponsor or other stakeholders, such as a CRO, and simply given to a research site to implement. The whole point is to reflect who, why, and how each step will be implemented (see the 'study walk-though method' above for ideas on how to liaise with the entire study team to generate SOPs).

There are many examples of SOPs available online - some examples are below and others can be located in 'External resources':

For downloadable templates and tools for clinical research, including SOPs, consult the Global Health Trials' Tools and Templates Library.

The CHAIN Network, Study Resources section has example SOPs and other useful tools and template.

Click here for example Standard Operating Procedures (SOPs) for clinical trials that meet NIH requirements. DGHI is pleased to share these documents with others who are working in resource-limited locations. Although most of these SOPs were developed for AIDS clinical trials, many of these documents can be modified and extrapolated to meet your specific project needs.

Click here for resources guidelines and templates for writing clinical research SOPs.

Assemble essential documents in Trial Master File (TMF)

The TMF is a file which contains all the documents for a study, it may be held in different formats e.g. paper and/or electronic and can be inspected by auditors and regulatory bodies. It is set up at the start of a study, with documentation added throughout the trial and is then archived at the end of the study. The TMF contains the trial’s essential documents and should include your protocol and any amendments. 

A commonly used framework for essential documents is described in ICH GCP E6 Section 8 and guidance on the TMF and Archiving is provided in Eudralex Volume 10 (EU Clinical Trial Guidelines).

ICH GCP definition of Essential Documents:

Essential Documents are those documents which individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, sponsor and monitor with the standards of Good Clinical Practice and with all applicable regulatory requirements. [ICH GCP].