Transcript SSP Manual Update 31 July 2012

SSP Manual Update
31 January 2014
Version 1.3
Overview of changes which affect
implementation
Overview and Version Control
Document
• While most SSP sections are now at V1.3,
remember that not every SSP section is updated
each time
• Current version number and release date of each
section is listed in the version control document
• Comments column highlights main updates for
that section, if applicable.
– Minor updates may not be detailed in the comments
column.
Section Updates Affecting
Implementation
• The following slides provide an overview of the SSP
Manual updates which affect study implementation.
– Updates incorporate previous guidance provided
through priority emails, operational guidance,
data communiques, etc.
• Some updates may be more administrative in nature
and will not be covered in this presentation.
• All sites are responsible to review the SSP changes in
full.
Section 2 - Protocol
• This section was updated to include
Clarification Memo #1, issued 7 August 2013,
in the list of current protocol documents.
Section 3 - Documentation
• Section 3.2.2: Added guidance to specify that addendums
made to chart notes should be signed and dated using the
date they were written
• Section 3.2.4: Bold text was added to reflect CM#1 language:
– Any lists, appointment books, or other documents that link
PTIDs to other participant identifiers (such as the
PTID/Name Link Log) should be stored securely (locked
cabinet/drawer if hard copy; password protected if
electronic) and it is recommended in a location separate
from individual participant records (that identify
participant by either PTID or name).
Section 3 - Documentation
• Appendix 3-1: Suggested Filing Structure for MTN020 Essential Documents, was updated to include a
File/Binder for Data Collection Tools, as these are
not included in the SSP Section 14 for ASPIRE.
– Case Report Forms (CRFs)
– Other data collection tools, as needed (e.g. In
Depth Interview (IDI) guides)
• Please ensure these are printed and filed
somewhere in your essential documents.
Section 5 – Informed Consent
• Section 5.9: Added guidance clarifying that if a
participant signs her name in a form that deviates
from the specifications outlined in the DAIDS
Source Doc SOP (e.g. she uses initials for both her
first and last names, or signs only using her first
name), sites should acknowledge this deviation
and verify that the mark represents the
participant’s signature as she wrote it. Sites may
work with OCSO to develop a standard memo to
document these deviations, if desired.
Section 5 – Informed Consent
• 5.10.1: If a participant changes her mind about
participating in one of the optional components of the
ASPIRE study (off site visits, qualitative component, long
term specimen storage):
• Use the most current version of the appropriate ICF and review
the information pertinent to the participant’s decision (e.g. if a
participant changes her mind about off site visits, review this
section of the consent).
• If the current ICF differs in any way from the version the
participant originally signed, these changes should be reviewed
with her as well.
• If reconsenting procedures are being conducted using an
enrollment informed consent that contains signature blocks all
items should be reviewed and re-signed based on the
participant’s current preferences.
• The signature lines at the end of the consent for participant,
staff, and witness (if applicable) must also be completed in full.
Section 6 – Participant Follow-up
• Section 6.4.3: Added guidance to specify that while there is
no formal restriction, sites should aim to do no more than 3
consecutive off-site visits for a participant due to the inability
to complete full safety evaluations (e.g. physical and pelvic
exams) during these visits.
• Section 6.5.3: Added reminder that sites must adhere to all
guidance provided by the LC for follow-up HIV testing plans
for participants who have positive rapid HIV tests that are
confirmed HIV negative by subsequent testing.
– For example, the LC may recommend using alternate approved HIV rapid tests
moving forward for these participants.
• Section 6.8: Added reminder that language fluency should be
considered in instances of participant transfer.
Section 7 – Visit Checklists
• Updates to 7.1:
– For items on the checklist that contain checkboxes,
one set of initials is sufficient, even if multiple boxes
are checked.
– Entering multiple sets of initials for one procedure
should be avoided as much as possible. If this is
happening on a regular basis, the site should consider
splitting the task into multiple items on the checklist
so each procedure receives only one set of initials.
• Updated appendices (previously posted to
website): Follow-up and Seroconversion
checklists Version 1.3, and PUEV version 1.4 to
PDF
Section 8 - Retention
• Section 8.4: Updated to specify that SMS and other
means of communication with participants may be
used throughout the ASPIRE trial assuming
participant permission is provided (e.g. via the
locator form, or documentation in chart notes, or a
site-specific tracking tool). All means of
communication must be in line with local IRB
guidelines.
• Section 8.7: Redundant text relating to voluntary
withdrawals was removed as it is more fully
addressed in section 6.9.
Section 9 – Study Product
• Section 9.3.2 (Preparing Used Rings for Storage) was
updated to reflect the ring collection procedures that
were issued per Operational Guidance #6.
• Section 9.6 was updated to reflect instructions for
completing the MTN-020 Vaginal Ring Request Slip
version 2.0 (removed guidance for version 1.0
completion).
– All sites should be using V2.0 request slips – please contact
Cindy Jacobson and SCHARP if you need these supplied.
Section 10 – Clinical Considerations
• Section 10.3.1, the following guidance was added
regarding trade names for medications (DC#9):
– It is preferable to record the trade name of a medication
on the CRF.
– If the trade name is not available or not reportable per
national guidelines, you may record the generic name of
the medication.
– A combination medication can be recorded as one entry
using the generic name.
– If a combination medication does not have a generic name
or the generic name is unknown, each active ingredient
must be reported as a separate entry in order to be
accurately coded at SCHARP.
Section 10 – Clinical Considerations
• Section 10.4.5 (Documentation of Exam Findings)
was updated to include guidance about
documentation of IUCD strings
– IUCD strings may be visible upon exam and are also
considered a normal finding. If documented, they should
be present on the non-DataFax Pelvic Exam Diagrams form.
Sites may determine whether they choose to consistently
document the presence of IUCD strings (best practice) or
not. It is recommended that if a participant has an IUCD
but the string not visible upon exam, this be documented
and followed up on.
Section 10 – Clinical Considerations
• Section 10.6.1 (Participant Report and Clinician
Assessment of Genital Bleeding) includes updates
about identification and documentation of genital
bleeding-related events (i.e. bleeding AEs, menses,
and unexplained infrequent bleeding)
• As with all SSP updates, relevant staff should ensure
the section updates are reviewed in full
• PLEASE SEE separate training slide set for genital
bleeding updates
Section 11 – AEs
• Details about reporting Vaginal Odor as an AE were added to
Section 11.3.1 (Reporting Genital, Genitourinary, and
Reproductive System AEs)
– Per the FGGT, odor is listed as a symptom and should be documented
as an AE if different from baseline and not due to a larger diagnosis.
This is based on participant report of the symptom, and grading based
on the participant’s perception of severity.
• The timeframe for ‘normal’ postpartum bleeding was clarified
in Section 11.3.3 (Reporting Considerations for Pregnant
Participants) – bold text added:
– In general, bleeding associated with delivery and the postpartum state
(the 6 weeks following delivery) is not considered an AE, provided the
bleeding does not exceed the expected amount
Section 11 – AEs
• A new section (Section 11.3.7) on Reporting HIV
Infection Illness was added. This guidance is the
same that was put out in Data Communique #10.
– “HIV infection” should not be reported as an AE or written
anywhere on an AE/GAE Log CRF (it is a primary endpoint)
– However, if a participant seroconverts and develops one or
more signs or symptoms of acute HIV- infection, it is
appropriate to report these sign(s)/symptom(s) as a single
AE using ONLY the term “seroconversion illness” for item 1
on the AE/GAE Log CRF.
• Use the comments section of the AE/GAE Log CRF to describe each HIVrelated sign/symptom (e.g., fatigue, pharyngitis).
– See section text for full details
Section 12 – Counseling
Considerations
• Added clarification to 12.1: Condom provision is
understood to mean that condoms are offered to
participants at each visit even though participants are
under no obligation to accept this offer and may decline
study-provided condoms at any time and for any reason.
• 12.2: Copper bearing IUD added to WHO-recommended
methods of emergency contraception. Site staff are
encouraged to incorporate information about emergency
contraception into the monthly contraceptive counseling
sessions in ASPIRE to increase participant understanding of
how emergency contraception works and its availability at
the clinical research site.
Section 13 - Lab
• Changed “Network Laboratory (NL)” to new name “Laboratory
Center (LC)”. This is new standard terminology from DAIDS.
• Added guidance that all HIV testing queries and algorithm
related notifications should be sent to
[email protected] using the MTN Network Lab
HIV Query Form (Appendix 13-5).
• Section 13.8.8 (Intra-Vaginal Ring Storage) was updated to
reflect the ring collection procedures that were issued per
Operational Guidance #6.
• Updated that MRC will be reading gram stains on site.
• References to associated text in SSP section 10 (clinical
considerations) was added to relevant sections.
Section 14: Data Management
• Addition of the Specimen Storage CRF to the CRFs
required at monthly visits for vaginal ring storage in
Table 14-3 – Schedule of Forms
• Removal of AE-1 form completion guidance for
related AEs within section 14.4. Guidance within
subsequent Data Communiques to replace and
clarify this guidance for all AEs reported to SCHARP
• Data Communiques #9 and 10 form completion
instructions added to sub-section 14.2.1
Section 16 - ACASI
• Guidance regarding the timing of ACASI after
permanent discontinuation that was only relevant
before LoA#2 was removed.
– All sites should now be operating under the following
schedule: …complete the PUEV/Discontinuers ACASI
questionnaire and the Ring Worries CRF at the visit the
discontinuation is initiated (or next regularly scheduled
visit if this is done at an interim visit).
• Other minor corrections made to figure labeling and
contact emails
Section 17: Study Reporting Plan
• Retention Report (Item 10) in section 17.2 has
been updated. The retention report now
includes a row to provide the number of
participants, excluding those who have early
terminated, who have completed each study
visit month.
• Section 17.2 now includes the AE Data Listing,
which provides MTN-020 Safety Physicians
with a cumulative listing of AEs for purposes
of safety monitoring.
Section 17: Study Reporting Plan
• New Retention Report Summary added to
SDMC Reports Posted on Atlas (Table 17-2
and Item 11)
• This new Summary Report includes:
– Cumulative visit retention over all expected visits, by site
– Cumulative visit retention for the last 3 months, by site
– Retention rates excluding participants who have
terminated early
Section 18 - Qualitative Component
• Clarifications were made about proceeding with 2nd or
3rd serial interviews in the event a participant is on product
hold or declining product
– These should generally proceed, eligibility criteria about being on
product only apply to 1st interview, but QMT can always be consulted.
• Clarifications about when to approach participants who are
terminating early about participation in a single IDI, and how
to document this conversation, were made.
– Most important thing is it should be documented clearly in the chart
notes that the participant is withdrawing consent, but is agreeing to
participate in one final interview and when this interview will
occur. Interview should occur prior to termination. Alternatively, if
she is not willing, document this.
Section 18 - Qualitative Component
• All interviewer-administered guides should be
administered in the preferred language of the
participant.
– This may be different than the language she provided
informed consent in, as long as fluency is
confirmed/documented in both languages (e.g. on the IC
coversheet and/or chart notes).
• To maintain neutrality and promote an open/free
environment, interviewers should be independent
from (i.e. not involved in) any study procedures that
will be discussed during the IDI or FGD.
Section 18 - Qualitative Component
• Referral of issues identified during interview:
– Timing: If the issue is ongoing, ideally follow-up should occur after
the interview is complete. However, if the issue is
historical/resolved at the time of the interview, follow-up may
occur at the next scheduled visit, per the discretion of the IoR.
– Maintaining rapport: Although the interviewer is required to share
information about these events with other appropriate ASPIRE
staff, she should aim to maintain a sense of trust, discretion and
rapport with the participant by explaining this referral. Some
sample language is provided in the SSP updates.
– Type of issues needing referral: was expanded to include
misunderstanding of key concepts that relate to study
participation/informed consent (e.g. placebo, randomization).
Section 18 - Qualitative Component
• Updates were made to the Transcription/Translation Process:
– QC should involve checks against the audio file.
– While it is ideal to have a staff member different from the
interviewer conduct the transcription/translation, it is
recognized this may not be feasible. If the interviewer does
conduct the transcription/translation, a separate staff member
fluent in both languages must QC these documents.
– Staff responsible for transcription must provide verification that
the transcript is an accurate and complete representation of the
original audio file through use of a coversheet. A template
audio transcription certification coversheet is available on the
ASPIRE website under MTN-020 Qualitative.
Questions???
• Please contact the ASPIRE management team
([email protected]) with any
questions regarding SSP v1.3 updates