RECIST 1.1 Criteria Toolkit: A Resource for Success in Clinical Trials with Solid Tumor Evaluation Requirements

February 08 2022

Written by the Quality Control and Communication Working Group

Part I. Getting Started
Many therapeutic oncology clinical trials require a specific way to measure solid tumor lesions. This specific criteria for measuring solid tumor lesions are known as RECIST which stands for Response Evaluation Criteria in Solid Tumors. This measures the effectiveness of cancer treatment(s) in an objective manner. The information obtained from RECIST tumor measurements is very important because it is needed to meet the endpoints for many solid tumor oncology clinical trials, which essentially determines future oncology treatment standards.

Prevention of mistakes is critical for research staff. There are serious consequences if RECIST criteria are not followed correctly, such as:

  • It can jeopardize the patient’s course of treatment if the investigator removes the patient from treatment too early or too late;
  • Inaccurately reporting and recording puts the institution(s) at risk for noncompliance; can compromise data integrity which could negatively impact study endpoint analysis;
  • It is extremely burdensome to staff to correct mistakes/answer queries and/or audit findings. Additionally, with staff turnover in oncology clinical research being high; new and inexperienced staff members can often be left to clean up the mistakes from previous research staff members;
  • Future oncology treatments are based on the data collected from clinical trial results. Therefore, inaccurate reporting could adversely affect the way investigators treat patients in the future.


Contributing causes that can lead to noncompliance issues at the practice site(s):

  • Inadequate training for RECIST criteria; research staff not knowledgeable of RECIST requirements;
  • Inconsistent practices and/orno formal procedure established at the practice site;
  • Responsibilities not clearly defined at the practice site, among research staff;
  • Unanswered queries and/or incomplete and missing data entries add a significant amount to workload;

Recommended Best Practices

  • Assess protocol specific requirements prior to activation of clinical trials that involve RECIST. It is important to confirm that requirements can be met before opening the trial.
  • Assign a designated radiologist(s), who is trained in RECIST, to read images per the protocol requirements.
  • Ensure in depth and ongoing training is made available for research staff who will be working in RECIST. RECIST Training sessions should include competency assessment components to assess skill level.
  • Establish and document a standard process/policy for solid tumor lesion evaluations that works for your institution. Re-evaluate the process regularly to verify effectiveness.
  • At baseline, designated radiologist and treating PI should agree on lesions to follow, for each subject who is enrolled to trials that involve RECIST criteria.
  • Delegate RECIST tasks appropriately on the study specific Delegation of Authority (DOA) log/Delegation Task Log (DTL).
  • Establish RECIST source documents prior to the activation of the trial and utilize consistently throughout the trial.
  • Ensure RECIST source documents are saved electronically and accessible to appropriate study team members.
  • For NRG trials, audit findings can include any of the findings listed within the CTMB Audit guidelines section, Review and share this list with research personnel who are involved in RECIST criteria.

Part II. FAQ’s

Q. Who should assess and document the overall response?
The enrolling investigator, who is authorized on the study, should assess and document the overall response throughout the study subject’s participation on the trial.

Q. How do I know who is responsible for RECIST related tasks?
The RT/Imaging support task can/should be assigned on the DTL, or the Delegation of Authority log. Also, having a specific Solid Tumor Evaluation research policy that defines roles and responsibilities can explain who is responsible for what tasks.

Q. What if a patient had imaging done at an outside hospital at screening and it meets the window for eligibility/study calendar requirements. Does that patient have to repeat the scan at the enrolling institution?
First, always check the protocol requirements. Some protocols may require all scans to be done at one location. It is the best practice to have all scans completed at the enrolling institution/practice site. However, the cost of scans can be a barrier. For example: additional scans might not be covered by a subject’s insurance. Always follow the protocol requirements and in situations in which the subject has had outside scans, consult with the enrolling physician to determine the best action.

Q. The designated radiologist for our institution did not include non-target lesions within the RECIST read. The auditor has issued a query for this and requests this information be added to the case report form. What do we do?
Discuss and share the finding with the radiologist and investigator to determine if in agreement. It may be necessary for radiologist to re-read the images and amend the image reports. If not in agreement with the auditor, a formal response would need to be provided and signed by the investigator, to explain the rationale.

Part III. Examples of Audit Finding related to solid tumor evaluation

  • Inaccurate documentation of initial sites of involvement;
  • Claimed response (i.e., partial response, complete response, stable) cannot be verified; or auditor could not verify the reported response;
  • Protocol-directed response criteria not followed;
  • Errors in submitted data; data cannot be verified;
  • Subject does not meet eligibility due to not meeting requirements of measurable disease;
  • Inconsistent method of scan used throughout trial;

Part IV. Resources

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