英文 |
A copy of any changes or renewals
of the informed consent form also must be sent promptly to the study monitor. |
a copy of the IRB-approved informed
consent form and other adjunctive materials |
A
parent or guardian of a minor patient must also read and initial each item
before signing the informed consent form. |
A sample case report form (CRF) is provided in Appendix 1, while
Appendix 2 contains a sample informed consent
form. |
Additional reference is made to the
above IND777, and to the model Informed Consent
Form for Study A sent to the regulatory authority
for review on May 1, 2017. |
After having been informed that participation is voluntary and that
the participants may withdraw from the study at any time, without prejudice,
the patient must sign the IRB- and sponsor-approved informed consent form in the
presence of a witness. |
After the informed consent form is read to
the subject and signed by the subject, the witness should also sign the consent form, attesting the subject
freely gave that informed consent. |
After the patient has signed the informed
consent form to participate in the study, a
registration sheet will be completed and faxed or emailed to the sponsor for
approval of entry of the patient onto the study. |
All concomitant therapies must be recorded throughout the study beginning with
signing of the informed consent form until the end-of-study visit. |
Anticipated benefits of the study drug and anticipated disadvantage to the
subjects must be described in the informed
consent form and explained to the subjects prior
to enrollment in this study. |
Any changes to the informed consent form suggested by
the investigator must be approved by the sponsor before submission to the
IRB, and a copy of the approved version must be provided to the sponsor's
monitor. |
Any changes to the informed consent
form suggested by the investigator must be
approved by the sponsor before submission to the IRB/IEC. |
Any updates to the informed consent form will be
provided to the subject. |
Appendix 1 contains a copy of a sample informed consent form. |
Before implementing this study, the
protocol, the informed consent form, and other information to subjects must be reviewed by a
properly constituted institutional review board. |
Before study initiation, the Investigator must have approval from the
IRB/IEC for the protocol, informed consent form, subject recruitment materials, and any other written
information to be provided to subjects. |
By signing this consent form, you agree to follow
your doctor's instructions, attend all study-related visits, and perform all
study specific assessments. |
By signing this consent form, you give the Sponsor permission to use material obtained from
your blood sample for the research described above. |
Company A has made the change to
the informed consent form for Study A, taking into account the available data. |
During a subject's participation in the study, any updates to the informed consent form and any
updates to the written information will be provided to the subject. |
Each subject
must sign the informed consent form after the nature of the study has been fully explained. |
Entries in the Case Report Forms are verified
using subject files, informed consent forms signed by subjects, drug accountability forms, and original
recordings from automated instruments, X-ray films, laboratory notes, etc. |
explanatory
materials and consent form used
for obtaining informed consent |
For the conduct of the phase III clinical studies, specific
language will be included in the informed consent
form to address the potential for impairment of
fertility. |
I will receive a signed copy of
this informed consent form. |
If an amendment substantially alters the study design or
increases the potential risk to the subject, the informed
consent form must be revised and submitted to the
IRB/IEC via the head of the study site for review and approval/favorable
opinion. |
If the original signed informed consent form will be
filed with the subject's source documents, a memo, describing that the
original informed consent form has been filed with the subject's source documents, should be
displayed in the Regulatory Binder. |
If the subject had no prior medical history or current conditions
at the time of signing informed consent form, select “No” and leave the rest of the CRF blank. |
If the subject is unable to read
the informed consent form, an impartial witness should be present during the entire
informed consent discussion. |
If written informed consent was obtained, enter the date informed consent form was signed by
the guardian or subject. |
If you decide that you do not want
to participate in this research, you may still participate in the clinical
study and receive the study drug if you have signed the informed consent form for the
clinical study and continue to qualify for the clinical study. |
If you decide to participate, you will be
asked to sign this informed consent form. |
In
a correspondence dated May 1, 2017, Company A accepted the regulatory
authority's recommendation and committed to submitting an updated version of
the model informed consent form
when it became available. |
Informed consent form will be sent to the subject beforehand, but will not be filled
in until the screening visit. |
Once you know about the study and
the tests that will be done, you will be asked to sign this consent form to join this study. |
Patients who meet all of the inclusion criteria and none of the exclusion
criteria described below and who agree to voluntarily sign the informed consent form will be
considered “enrolled” into the study. |
Preparation of the informed consent form must adhere
to GCP and to the ethical principles that have their origin in the
Declaration of Helsinki. |
Prior to performance of any study-related activity, the informed consent form should be
signed and dated by the subject or his/her legally acceptable representative
and by the person who conducted the informed consent discussion. |
Proposed
text for inclusion in the informed consent form is as follows: … |
Samples collected for exploratory pharmacogenetic analysis will be
retained for up to 15 years, as indicated in the informed
consent form. |
Signing
this consent form does not
take away all of your legal rights. You still have rights as a participant in
a study. |
Subjects and legally acceptable
representatives must sign an informed consent form after the nature of the study has been fully explained and all
questions have been answered to the subject's satisfaction. |
The "Track Changes"
mechanism in Microsoft Word should be used when making changes to the informed consent form. |
The contract research organization (CRO) must
approve all informed consent forms used in the study prior to submission to the IRB. |
The
date the first subject signs a study-specific informed
consent form will be defined as the start of the
study. |
The document should include the date the subject signed the informed consent form and that a
signed copy was given to the subject. |
The
impartial witness should sign and date the informed
consent form attesting that the information is
accurate. |
The informed consent form and any other written information provided to the subject should
be revised whenever important new information becomes available that is
relevant to the subject’s consent. |
The informed consent form must include a statement that the sponsor and regulatory
authorities have direct access to subject records. |
The informed consent form must be dated
and signed prior to any screening procedures. |
The informed consent form must have been approved by the sponsor and the investigator's
institutional review board. |
The informed consent form should also
provide an explanation of the potential risk associated with QT interval
prolongation in language that can be understood by the patients. |
The informed consent form should be updated or amended whenever new information becomes
available that may be relevant to the subject. |
The informed consent form should
include all requirements according to local law. |
The
institutional review board or ethics committee must review this protocol and
the informed consent form prior
to initiating this study. |
The investigator making the explanation must date and sign or seal the informed consent form to make the
consent effective. |
The investigator must keep a copy
of the signed informed consent form. |
The investigator must obtain the Institutional Review Board's written approval
of the informed consent form and any other written information to be provided to the
subjects via the head of the study site, prior to the beginning of the study. |
The investigator must provide the
subject or legally acceptable representative with a copy of the informed consent form and written
information about the study. |
The investigator must provide the subject or legally acceptable representative
with the informed consent form and written information about the study in language that is
non-technical and easily understood. |
The investigator must provide the
subject with a copy of the informed consent form and written information about the study in language that is
non-technical and easily understood. |
The investigator must revise the informed consent
form whenever important new information becomes
available that is relevant to the subject's consent. |
The investigator should allow time
necessary for the subject to inquire about the details of the study, then the
informed consent form
must be signed and dated by the subject and the person who conducted the
informed consent discussion. |
The medical expert will assist in creating and reviewing all study-related
documents, including the sample informed consent
form and the investigator's brochure. |
The protocol and the informed consent form were reviewed
and approved by the investigator's IRB before initiation of the study. |
The protocol and the informed consent form will receive Institutional Review Board (IRB)/Independent
Ethics Committee (IEC) approval/favorable opinion prior to initiation of the
study. |
The
purpose of this informed consent form is to give you information so that you can decide whether you
want to provide an additional blood sample(s) in conjunction with the
clinical study of Drug A in which you may participate. |
The required topics to be included in the informed consent form are listed in
Appendix 1. |
The
revised informed consent form
must be used to obtain consent from subjects currently enrolled in the study. |
The sample informed consent form will adhere to the ethical principles that have their origin
in the Declaration of Helsinki. |
The sponsor must have a copy of
written and dated approval from the Institutional Review Board for the
protocol, informed consent form, subject recruitment materials (e.g., advertisements), and any
other written information to be provided to subjects. |
The sponsor will provide the investigator with an appropriate sample informed consent form which will
include all elements required by ICH, GCP, and regulatory requirements. |
The study drug will not be
distributed to an investigator until the institutional review board (IRB) or
ethics committee has provided written approval of the study and informed consent form to the
investigator. |
The subject agrees, when signing the informed
consent form, that they will not be provided with
the results from the research, nor will the results be available at any time. |
The
subject must sign an informed consent form documenting this discussion. |
The subjects will be asked to read and understand an informed consent form designed
specifically for the purpose of collecting a blood sample for genetic
research. |
This
consent form tells you about
the study that you may wish to join. |
This consent form may contain words that you do not understand. |
This
informed consent form should
only be modified to the extent necessary to meet applicable legal
requirements. |
This page is
used to collect all prior psoriasis therapies up to the point when the
subject signed the informed consent form. |
Upon signing the informed consent form, the patient
is assigned the sequential number by the Investigator. |
When the patient has signed the informed
consent form, the investigator or his/her staff
will telephone the Committee and provide the identifying information for the
patient. |
You will be asked to sign a
separate consent form
for the extension study. |
You will be asked to sign an informed consent form at screening. |