Edit RACT Working Draft

To continue setting up your study’s risk assessment after selecting a Catalog navigate to Risk Management → RACT. Here you can see all details of your current working document, which can be edited until its release. To switch to the editing mode click Edit Working Draft or Continue Editing.

The first object that meets your eye is the summary of already finished risk assessments. It shows the categories, the evaluated properties of risks (Impact, Probability, Detectability) and the risk priority number.

Navigate through the risk categories at the top of the page, or by clicking on Next Category/Previous Category at the bottom of the page.

To edit Category Name and/or add a New Category:

TransCelerate suggests the following categories to organize study risks:

• Safety
• Study Phase
• Study Complexity
• Subject Population
• Technology
• Data Collection Procedures
• Study Endpoints
• Organizational Experience
• IMP Supply Chain
• Blinding
• Operational Complexity
• Geography

Each category consists of one or multiple questions that act as a guide for risk identification. Navigate through the questions by using the Question Summary in the wizard mode, the Next open question button, the Search bar, and the Answered, Unanswered, and Disabled filters.

To add a new question to the Category or edit existing question:

Questions in RACT can't be deleted, but they can be disabled. Disabling a question hides its related risks from RACT and inactivates it for all internal processes, but does not delete it. Re-enabling the question at any time brings those risks back into view.

Each added question opens a pre-defined risk form with a fixed risk statement structure If – Due to – Then, risk scoring, a risk type selector, and links to critical data and processes.

To create a risk, enter its event, cause, and impact. Team members involved in risk identification should, above all, focus on the identification of risk threats:

• human subject safety
• human subject rights
• critical study processes and critical data of the pertinent clinical study
• risks to:
  • quality requirements
  • scope
  • schedule
  • budget
  • team
  • deliverables
  • outcome and
  • IT systems (e. g., communication tools, electronic files, data capture systems)

After filling in a risk, evaluate the severity of risk impact (I), the probability of occurrence (P) and detectability (D) by assigning a score (from 1 to 3, higher scores meaning higher risk) to each of these three attributes. I, P and D scores are multiplied to obtain a single score for each risk, the so‑called Risk Priority Number (RPN).

The assigned risk scores allow for single and grouped risk prioritization and the calculation of a total risk score for each clinical study.

After assessing risk attributes, optionally select a risk type and associate it with Critical Processes and Data, to make sure all critical to study items are covered by risks.

Click Add another risk to add more, or Delete this risk to remove one — each question must have at least one risk.

When done with all questions and risks within one category, move to the next one, until the assessment is finished. Don’t forget to save changes for each category. When everything has been filled in, Release the RACT working draft by clicking on Release Draft.

By default, the system asks for a rationale in three places: disabling a question, accepting a risk, and releasing a RACT Working Draft (one general rationale).

To require a rationale for every saved change instead, go to Company Settings → Company Management → RACT Customization and tick Ask for a rationale for any saved change in RACT Working Draft. Either way, all saved rationales stay visible in the Study Audit.