Known Potential Benefits Include a discussion of known potential benefits based on both clinical and nonclinical studies/data. Note that payment to participants is not considered a Provision of care” “benefit.” “intensified is also not to be considered a benefit. Assessment of Potential Risks and Benefits Include an assessment of potential risks and benefits, addressing each of the following: rationale for the necessity of exposing participants to risks and a summary of the measures to minimize the risks to participants, justification of the risks in relation to potential benefits. Selection of trial population The characteristics of the trial population should be described in medical terms. If necessary, the reasons for including, for example, children or subjects who are unable to give informed consent must be given and the measures taken to ensure the welfare of such groups must be described. Reasons for gender distribution The expected gender distribution must be given, as well as the reasons why this distribution in the population affected appears adequate to detect any gender-specific differences in efficacy or safety of the pharmaceutical preparation under testing. If appropriate, a cross reference to Section 6.1.5 should be added. Inclusion criteria Trial indication A general rule is that inclusion and exclusion criteria should be described as unequivocally as possible. The inclusion criteria should also include the methods used to verify the indication (e.g. demonstrated by coronary angiography that must be available in the trial “findings subject’s records, not conducted earlier than 2 months before” or the discretion of the “at principal investigator/subinvestigator based on the trial subject’s medical history”). It must be kept in mind that inclusion and exclusion criteria may sometimes require trial-related (e.g.
Known Potential Benefits Include a discussion of known potential benefits based on both clinical and nonclinical studies/data. Note that payment to participants is not considered a “benefit.” Provision of “intensified care” is also not to be considered a benefit. Assessment of Potential Risks and Benefits Include an assessment of potential risks and benefits, addressing each of the following: rationale for the necessity of exposing participants to risks and a summary of the measures to minimize the risks to participants, justification of the risks in relation to potential benefits. Selection of trial population The characteristics of the trial population should be described in medical terms. If necessary, the reasons for including, for example, children or subjects who are unable to give informed consent must be given and the measures taken to ensure the welfare of such groups must be described. Reasons for gender distribution The expected gender distribution must be given, as well as the reasons why this distribution in the population affected appears adequate to detect any gender-specific differences in efficacy or safety of the pharmaceutical preparation under testing. If appropriate, a cross reference to Section 6.1.5 should be added. Inclusion criteria Trial indication A general rule is that inclusion and exclusion criteria should be described as unequivocally as possible. The inclusion criteria should also include the methods used to verify the indication (e.g. “findings demonstrated by coronary angiography that must be available in the trial subject’s records, not conducted earlier than 2 months before” or “at the discretion of the principal investigator/subinvestigator based on the trial subject’s medical history”). It must be kept in mind that inclusion and exclusion criteria may sometimes require trial-related (e.g.
Trial_Protocol_Template_V08.docx