Frequency of Radiological Imaging Form

SJGHC regard it as the Sponsor's responsibility to justify the frequency of radiological imaging in clinical trials,
as what is considered "standard of care" can vary between patient populations, indications and individual clinicians.

Study Title

Short Title/Acronym

Sponsor Name

Proposed SJGHC Site

Study Design

Indication

Treatment

Frequency

Radiological Imaging

Type of Scan/s

Frequency of Scan/s

Effective Dose Range

Clinical Need/Valid Clinical Reason(s) for imaging (please select all that apply)

Previous imaging investigations cannot be relied upon

The question(s) to be answered by the imaging cannot be answered any other way/via alternative clinical examination

Imaging that does not employ ionising radiation is not a viable alternative

A reduction in viable tumour tissue is a good prognostic marker for the long term outcome of the patient

Other

Optimal scan frequency based on (please select all that apply)

Patient characteristics

Patient prognosis/outcome

Tumour type/characteristics/dynamics

The location and extent of metastatic involvement and incurable malignancy

Treatment type

Intent of treatment

Toxicity of treatment

Regimen of treatment

Phase of study and extent of existing safety and efficacy data on study treatment/therapy

Study design

Schedule Optimizing studies

Population kinetics approach

Other

Potential benefits of the imaging significantly outweigh the risks involved (please select all that apply)

Prognosis Evaluation studies

Pharmacoeconomic assessment

The exposure to ionising radiation is limited to more than 5 mSv but less than 20 mSv above standard of care

Other

Signature

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Name

Date

Role

Affiliation

Email Address

Additional Email Address to CC

SJGHC Frequency of Radiological Imaging Form Version 1.1 dated August 2022

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