1.
OBJECTIVE
1.1 The purpose of this
SOP is to describe the procedures for Audio-Visual (AV) recording, storage, and archival
of the informed consent and assent process for regulatory studies conducted at the
site.
2. PURPOSE
2.1 This standard operating
procedure (SOP) describes the communication between key research personnel at the site
and the sponsor/Contract Research Organization (CRO), including telephone and
written interactions, during the entire course of a research study conducted at
Site and to ensure proper documentation of communications with the Sponsor/CRO
concerning study activities.
3. SCOPE
3.1 This
SOP applies to communications between the site and sponsors/CROs involved in
the conduct of the research study.
3.2 This SOP also applies
to all those regulatory clinical trials, approved by the DCGI, which require
documentation of the written informed consent and assent process.
3.3 These communications
serve to protect the safety and well-being of subjects by assuring that studies
are conducted compliantly, sponsors/CROs are fully appraised of study site
activities, and key research personnel is informed of new information about
the study provided by the sponsor/CRO.
3.4 Any new study initiated during the active period of the SOP will be covered under the SOPs unless otherwise indicated. If necessary, a study-specific SOP may be prepared.
4. PROCEDURE
4.1 General Communications
4.1.1
Provide the sponsor/CRO a contact list of site
personnel involved in study start-up, along with each individual's role and
responsibilities.
4.1.2
Communicate regularly, courteously) and in
accordance. with Site," standards, with the sponsor/CRO about all study-related issues.
4.1.3
Be familiar with the sponsor's SOPs
pertaining to communications, including reporting timelines and preferred communication
nodes.
4.1.4
Keep originals or photocopies of all
study-related communications, including faxes with corresponding confirmations.
e-mails, and written summaries of phone conversations.
4.1.5
File all communication documents in the
appropriate section of the SITE MASTER FILE.
4.1.6
Retain all sponsor-generated
communications regarding the conduct of the study (e.g. Teleconference announcement)
in the correspondence section of the SITE MASTER FILE. Budget, payment, and other
contractual or financial communications should be filed separately from the
regulatory binder. Ensure information is communicated to the Principal
investigator (Pl) and other key research personnel as applicable.
4.2 Pre-Study communication
4.2.1
The clinical trial coordinator is
responsible for sending the Confidentiality Agreement to the sponsor/CRO once
reviewed and signed by the PI.
4.2.2
Notify the sponsor/CRO of the PI's
decision to conduct the research study at the Site.
4.2.3
Review the protocol and submit any
questions concerning the interpretation of the protocol or conduct of the study to
the sponsor/CRO in writing and file the copy in the Site Master File.
4.2.4
Fill out the questionnaires provided by the
sponsor/CRO regarding the study-related requirements.
4.2.5
Prepare questions to clarify protocol
procedures. subject eligibility criteria. and other study-related issues in writing
and file the reply in the Site Master File.
4.2.6
The 'Pl/Co I will discuss how the site is
equipped to perform the study. This discussion will include a description of the
potential subjects available for the study and methods being considered for
recruitment.
4.3 Communications while the study is ongoing
4.3.1
Investigator / Clinical Trial Coordinator
will submit the updated screening and/or enrollment logs to the sponsor/CRO by
the preferred mode of communication.
4.3.2
Notify Sponsor/CRO about unanticipated
issues, including adverse events (AEs) and Serious Adverse Events (SAEs), per
the sponsor's definitions and timelines, as defined in the protocol or, SOP.
4.3.3
Communicate protocol deviations. as they
occur, according to the sponsor requirements.
4.3.4
Submit completed CRFs (paper-based or e-CRF)
to the sponsor/CRO in accordance with the Clinical Trial Agreement (CTA).
4.3.5
Respond promptly to data queries as requested
via fax. e-mail, and/or direct electronic data capture resolution, per the
sponsor's requirements and document the same in these specified Site Master
File.
4.3.6 Communicate significant regulatory changes
per the sponsor's requirements (e.g.' SEC acknowledgment of unanticipated
issues or protocol deviation, IEC approval of a revised consent document,
etc.). Typically, these documents are reviewed during interim monitoring
visits; however specific sponsors/CROs may require prompt notification in
specific circumstances,
4.3.7
Submit sponsor-generated protocol
amendments to the IEC. Once approval is obtained, the PI will train the study team
regarding the changes prior to implementation, and the same will be documented and
informed to Sponsor/CRO
4.3.8
Forward safety reports received from the
sponsor (e.g. off-site SAE/------) to the PI who will review the event and
report to the IEC as per IEC SOP. Notification of other key research personnel
and/or enrolled subjects may be necessary (e.g., new risk identified related to
investigational treatment).
4.4 Communication after the study is
completed
4.4.1
Inform IEC regarding the scheduled site close-out visit.
4.4.2
Communicate with the sponsor and confirm the
close-out date.
4.4.3
Provide the sponsor/CRO with any IEC-required correspondence (e.g. information requires in the IEC study closure
letter) related to the study close-out.
4.4.4
Ensure that all close activities are
performed and all sponsor's requirements are met,
4.4.5
After receiving the final close-out letter
and study result from the sponsor, submit the same to the IEC in the required IEC
format.
4.4.6
File all the communication in the
appropriate section of the SITE MASTER FILE
4.5 Sponsor Contact
4.5.1
Telephone Contacts All study personnel
will document critical conversations with the Sponsor/CRO in the source notes,
especially those pertaining to eligibility criteria, protocol deviations, and
serious adverse experiences. If requires the CLINICAL TRIAL COORDINATOR or
delegate will file, the Telephone Contact copy in the SITE MASTER FILE.
4.5.2
Letters and Faxes. - All study personnel
will make copies of all correspondence written to the Sponsor/CRO. The
CLINICAI-TRIAL COORDINATOR or delegate will file this correspondence in the SITE
MASTER FILE.
4.5.3
e-mails - All study personnel will print
out copies of critical e-nails with the Sponsor/CRO. The Clinical -trial
coordinator or delegate will file this correspondence in the Site Master File
and if required ln the source notes.
4.5.4
At a minimum, the Sponsor/CRO should be notified:
4.5.4.1
When the first subject is controlled in a trial study.
4.5.4.2
When there is a question concerning a
potential subject's eligibility
4.5.4.3
When recruitment issues occur.
4.5.4.4
When a protocol violation occurs.
4.5.4.5
When an SAE occurs.
4.6 Applicable Staff
4.6.1
This SOP applies to all the personnel of
the clinical research team involved in communication with the Sponsor/CRO and
responsible for the management of the data.
4.6.2
These include the following:
4.6.2. Principal Investigator
4.6.2.2. Sub Investigator
4.6.2.3 Clinical Trial Coordinator
4.6.2.4 Pharmacist
4.6.2.5 Support Staff
4.7.1 AV recording of the entire informed consent process is mandatory for all clinical trials (as mentioned in GSR 6l l(E),31'' July 2015) approved by the DCGI, and consent for the same should be taken.
4.7.2 AV recording for any re-consenting procedure that may follow must be done.
4.7.3 If the participant is unable to give consent for medical or legal reasons" the consent should be taken lion the legally acceptable representative (LAR) and the process recorded.
4.7.4 If the participant/LAR is illiterate, then an impartial witness is needed. This person should also be in the 1'rame for the entire duration of the consent process.
4.7.5 AV recording should be done of the assent process wherever applicable.
4.7.6 Separate recordings one for assent and one tor-consent process should be done.
4.8 Ensure the following. infrastructure is available prior to counseling of potential participants:
4.10.1 The Pl/Co-l/medically qualified person
delegated by the PI and the potential participant/LAR (and if need be the
impartial witness) should sit conformably facing each other/side-by-side in
such a way that their laces will be captured in the frame simultaneously.
4.10.2 The PI/Co-l/medically qualified person
delegated by the PI should introduce herself/himself by name, designation, and
her/ his role in the research, and state the current date and time. Mention the
title of the protocol and the screening number of the participant.
4.10.3 Participant/LAR should be requested to
introduce her/his name, age, and address in case of LAR. she/he should
clearly state the relation to the actual participant as well as the reason why the participant
cannot give consent. Participant/LAR should also state the language she/he
understands best and is literate in. The Pl/Co-l/medically qualified person
delegated by the PI may facilitate this process to ensure all the above points are captured
in the recording.
4.10.4
In case the participant/LAR is illiterate then
an impartial witness is needed, the impartial witness should be requested to
introduce herself /himself, give her/his address, and state the language that
she/he is literate in.
4.10.5
The participant should be allowed to read
the consent document (and this process should be recorded).
4.10.6 The Pl/Co-l/medically qualified person
delegated by the PI should explain all the elements of the approved ICF in the
language best understood by the potential participant.
4.10.7 Explanation or narration given by the
PI/Co-l/medically qualified person delegated by the PI, all the questions asked
by the potential participant/LAR, and answers given to them should be clearly
audible and recorded.
4.10.8
At any point during the consent process,
if the participant wishes to take more time to read/ understand the consent
document, including, for example, taking it home to discuss with relatives the
recording shall be stopped mentioning the time of stopping. When she/he returns,
the recording from the point where it was stopped before shall be resumed as mentioned
before stating clearly again the date and time of recording.
4.10.9 lf the potential participant/ LAR (wherever applicable) agrees to participate in the trial. she/he should be asked questions to assess het/his understanding of the informed consent process. (Please refer to Appendix l- Informed consent process assessment tool)
1. The participant/LAR (wherever applicable) should be invited to sign (or attest left-hand thumb impression) the consent form only after satisfactory answers (in the investigator's judgment) have been given by the participant/ LAR to all the above-mentioned questions.
2. Participant/LAR should read out all the statements mentioned in ICF and state whether she/he agrees or not for each statement and affix a signature/thumbprint at the end.
3. The actual signing process (or attesting left-hand thumb impression) should be recorded.
4. The impartial witness should be requested to enter the name and details of the participant and the date the consent is documented. The impartial witness will also be requested to sign and date the consent form.
5. The Pl/Co-l/medically qualified person delegated by the PI will also sign and date the consent form al the end of the process.
6. The recording will be stopped after thanking the participant.
7. The recording should be checked the by PI/Co- l/medically qualified person delegated by the PI for completeness and clarity of 'both audio and video recording using a dedicated laptop (site's own / provided by the sponsor) in which the original recording will be store
8. No editing should be done on the recording so as to maintain the authenticity
9. The laptop should be password protected. The password will be known only to the Pl and members of the study team as designated by the PI. Each time the laptop is accessed; this should be entered into the designated register
10. The recording should be then transferred to a CD labeled according to the study name, the unique identifier assigned to the participant, the date and time of the recording, and no. of recordings (applicable during re-consenting) and archived in an external hard drive. The hard drive will remain with the PI which could be accessed by the delegated study team members on request for transferring and storage 'The CD) should be filed in the participant binder.
4.11
Archival
4.11.1
One CD per participant will be archived
with appropriate labeling in the participant binder
4.11.2
The soft copies of the recordings will
also be stored in a password-protected hard drive
4.11.3
The original recording in the laptop will
be deleted when the study is closed out.
4.12
Applicable
Staff
4.12.1 Principal
investigator, Co-investigator of any other medically qualified member of staff
in the team, as delegated by the Principal Investigator, who has the
responsibility of obtaining informed consent, will also be responsible for
ensuring AV recording of the informed consent process, storing and archiving without
violating the participant confidentiality.
5.
ENCLOSURE
Appendix
Tool to assess understanding of informed consent document
by participant*
l. Do you understand that this is
research?
2. Is the purpose of the research clear to
you?
3. Will you get the treatment that the
doctor links is best for you?
4. What are the potential risks involved
in this study?
5. What are the potential benefits of participating
in this study?
6. Have you understood that you will
receive --------- amount in consideration for your participation (if normal volunteer)
or in consideration for your travel expenses (if patient)
7. Do you understand that participation in
this research is voluntary?
8. Have you understood that you may
receive either the test medicine of the active comparator - a drug used in
therapy currently or a placebo?
9. Have you understood what you should do
if you suffer any untoward event?
10. Do you understand that you can withdraw
from the research at any time without giving a reason and without it affecting
your regular care?
11. Do you know whom to contact if any questions
regarding this clinical trial?
12. Do you know whom to contact in an emergency or if any injury occurs during your participation in this clinical
trial?
13. Have you understood that if you suffer
any serious injury during your participation, you will get free medical
treatment and will be compensated for this injury if it is related to the
trial?
14. Has anybody forced, induced,
influenced, allured, or pressurized you to agree to participate in the clinical
trial?
15. Do you understand that none of your
legal rights will be waived by participating in this research?
16. Have you understood the study procedures
explained to you? (number of study visits, number of times blood or any
biological sample donation, amount of blood draw per visit, etc)
17. Have all your questions about the
research been answered?
18. Have you understood that your
information about participation and also video recording will be kept confidential?
*' This is a model questionnaire that can
change according to protocol and Informed Consent document (ICD).
6.
ABBREVIATIONS
6.1
SOP : Standard
Operating Procedure
6.2 CTA : Clinical Trial Agreement
6.3 DGHS : Director General of Health Services
6.4 DCGI : Drugs Controller General India
6.5 ICD : Informed Consent Document
6.6 CRO : Contract Research Organization
6.7 PI : Principal Investigator
6.8 CRF : Case Report Form
6.9 ICMR : Indian Council of Medical Research
6.10 ICH : International Conference on Harmonization
6.11 SAEs : Serious Adverse Events
6.12 LAR : Legally Acceptable Representative
6.13 IEC : Institutional Ethical Committee
6.14 ICF : Informed Consent Form
6.15 AV : Audio Visual
6.16 AEs :
Adverse Events
7. REFERENCES
7.1 Order from Director General of Health Services (DGHS), Ministry of Health and Family Welfare,
7.2 Office of Drugs Controller General (India), F.No. GCT/ Z0/SC/Clin./2013 DCGI dated 19th November 2013 (Available on http://cdsco.nic.n/Office%20Order%20dated%)l9.11.20l3.pdf)
7.3 Schedule Y (Jan 2005) (Available on http://cdsco.nic. in/html/scheduleyYo20(amendedVo20version-2005)%20original.html)
7.4 Ethical Guidelines for Biomedical Research on Human Participants, ICMR2006 (Available on http://icmr.nic. in/ethicalguidelines.pdf.
7.5 International Conference on Harmonization; Good Clinical Practice Guidelines: May 1996(Available on http://www.ich.org/f'ileadmin/public_Web_Site/ICH_Products/guidelines/Efficacy/E6_R1/Step4/E6_Rl_Guideline.pdf)
7.6 Indian GCP 2001 (Available on http://cdsco.nic.in/html/GCP.htm)
END OF THE DOCUMENT
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