Standard Application Form For The Ethical Review Of Health-Related Research Studies, Which Are Not Clinical Trials Of Medicinal Products For Human Use As Defined In S.i. 190/2004 Page 16
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24Version 5.5
May 2011
Office Use:
-
REC Reference No:__________
SECTION G
RADIOACTIVE MATERIAL / DIAGNOSTIC OR THERAPEUTIC
IONISING RADIATION
G1
RADIOACTIVE MATERIAL / DIAGNOSTIC OR THERAPEUTIC IONISING
RADIATION - GENERAL
G1.1 (a) Does this study/trial involve exposure to radioactive materials
or does this study/trial involve other diagnostic or therapeutic ionising
radiation?
Yes / No
If the answer to question G1.1(a) is No, please delete the following questions in this
Section.
G1.1 (b) If yes, please specify:
Exposure to radioactive materials
Yes / No
Therapeutic ionising radiation
Yes / No
Diagnostic ionising radiation
Yes / No
G1.2 (a) Does this study / trial involve additional radiation exposure to
radioactive materials or diagnostic or therapeutic ionising radiation other
than normally received as part of standard care?
Yes / No
G1.2 (b) If yes, please elaborate
Answer
G1.3. Is this an application to conduct research involving radioactive
materials or diagnostic or therapeutic radiation at a radiation
oncology unit?
Yes / No
SECTION G2 RADIOTHERAPY TRIALS
G2.1 Does the study/trial involve patients?
Yes / No
G2.2 If yes, will the patient receive radiotherapy?
Yes / No
G2.3
Is the radiotherapy part of standard treatment or is it
experimental?
Standard treatment / experimental
16 |
P a g e
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