mtn-034 study-specific procedures manual overview and control document version … ·...

MTN-034 Study-Specific Procedures Manual Overview and Control Document – Version History and Notice of Changes

MTN-034 Overview and Control Document, Version 1.3, Protocol Version 2.0, Updated 22JUL2020 Page i-1 of i-10

Section Number

Section Title Version

Number(s)* Version Date(s)*

Notice of Changes*

01 Introduction

1.3 22 July 2020 Section 1.1 o Added Protocol V2.0 Clarification Memo #01 and #02, and LoA #03 o Added language regarding potential rapid changes to study implementation due

to COVID-19, including applicable reporting requirements to regulatory bodies and documentation requirements in the study database

02 Documentation

1.2 22 July 2020 Section 2.2 o Changed laboratory “records and notes” to “reports or logs”

Section 2.9 o Added language regarding reporting of COVID-19 related protocol deviations

and noting COVID-19 relatedness on the Missed Visit CRF

03 Accrual and Retention 1.3 22 July 2020 Section 3.2

o Updated accrual targets to match actual accrual numbers

04 Informed Assent and Consent

1.1 01 July 2019 N/A – no updates

05 Study Procedures

1.3 22 July 2020 Section 5.5 o Added COVID-19 Behavioral Assessment CRF administration o Added note regarding potential delays to drug level feedback results due to

COVID-19

Section 5.6 o Added instructions regarding COVID-19 Behavioral Assessment CRF

administration upon HIV confirmation

Section 5.7 o Added instructions regarding COVID-19 Behavioral Assessment CRF upon a

positive pregnancy test

Section 5.12 o Added reference to the sample study exit worksheet

06 Study Product 1.3 22 July 2020 Section 6.9

o Added language to reinforce completion of the study product accountability log

07 Clinical Considerations 1.3 22 July 2020 Section 7.4

DocuSign Envelope ID: C2EC94E1-C758-43DD-8C34-D4C5BB8AD995



Section Number



Notice of Changes*

o Added guidance for blood pressure assessment and AE reporting for participants under 18 years of age per LoA #03

Section 7.7 o Added acute seroconversion assessment sub-section, including reference to

COVID-19 clinical assessments which may have indistinguishable signs and symptoms

08 Adverse Event Reporting and Safety monitoring

1.3 22 July 2020 Section 8.1 o Added new fields from AE Log CRF regarding AE relatedness (i.e. ring or tablet

and device or drug)

Section 8.3 o Added clarification on reporting requirements and AE terminology for

unexpected, abnormal bleeding related to contraception or menses; and confirmed or suspected COVID-19 infection

Section 8.7 o Added Grade 3 AEs to the subset of AEs that must be reassessed after study exit

09 Laboratory Considerations

1.3 22 July 2020 Section 9.4 o Added instructions for using web access to LDMS

Section 9.6 o Added instructions for HIV-1 genotyping o Added explanation regarding potential shipping disruptions related to COVID-19

Section 9.7 o Included further instructions for indicating ring order in LDMS

10 Counseling Procedures

1.3 22 July 2020 Section 10.4 o Noted that ring placement may also occur in the participant’s home

Section 10.6 o Noted that drug level result feedback may be delayed due to COVID-19 and

sites are not expected to provide delayed results unless requested by participants

Section 10.8




Section Number



Notice of Changes*

o Noted that counselors should prioritize counseling over audio recording, if sessions are conducted by phone

11 Behavioral Assessments

1.3 22 July 2020 Section 11.2 o Added COVID-19 Behavioral Assessment CRF to list of behavioral assessments

Section 11.3 o Added guidance for IDIs in case of seroconversion o Added flexibility to conduct IDIs in lieu of late FGDs due to COVID-19 o Added clarification to late FGD stratification by adherence level

12 Data Collection 1.3 22 July 2020 Section 12.5

o Updated REACH website link o Added COVID-19 Behavioral Assessment CRF to table of forms

13 Data Communiques 1.0 04 January 2019 N/A – initial version

Note: Data Communiqués 1-7 available on REACH website

14 Study Reporting Plan 1.3 22 July 2020 Section 14.2

o Added COVID-19 specific reports to list of Atlas reports

*Highest version number/date listed is current and supersedes all previous listed version(s). Notice of Changes summarizes any significant changes that have been made during the current review period.




SSP Approval Sheet Review Period: 14JAN2020-22JUL2020

Entity Sections Approved* Print Name, Role Signature/Date

Protocol Chair All Sections Gonasagrie Nair, Protocol Chair

*Applicable section version numbers and dates as listed in MTN-034 Overview and Control Document, Version 1.3, Protocol Version 2.0, dated 22 July 2020.






FHI 360 CRM All Sections Morgan Garcia, FHI 360







MTN Pharmacy Director Section 6 Cindy Jacobson, MTN LOC







Protocol Safety Physician Sections 7,8 Katherine Bunge, UPMC

*Applicable section version numbers and dates as listed in MTN-034 Overview and Control Document, Version 1. 3, Protocol Version 2.0, dated 22 July 2020.






MTN LC Research Manager

Section 9 Edward Livant, MTN LC







BRWG Project Coordinator Section 11 Sarah Roberts, RTI






Entity Sections Approved*

Print Name, Role Signature/Date

SCHARP CDM Sections 12, 13, 14 Jennifer Schille, SCHARP



Certificate Of CompletionEnvelope Id: C2EC94E1C75843DD8C34D4C5BB8AD995 Status: Completed

Subject: MTN-034 SSP Overview-VersionControl_V1.3_22JUL2020

CF02:

Project Code/Charge Code: 900065000001

Source Envelope:

Document Pages: 10 Signatures: 7 Envelope Originator:

Certificate Pages: 6 Initials: 0 Morgan Garcia

AutoNav: Enabled

EnvelopeId Stamping: Enabled

Time Zone: (UTC-05:00) Eastern Time (US & Canada)

359 Blackwell Street, Suite 200

Durham, NC 27701-2477

[email protected]

IP Address: 108.247.36.36

Record TrackingStatus: Original

7/23/2020 11:32:57 AM

Holder: Morgan Garcia

[email protected]

Location: DocuSign

Signer Events Signature TimestampCindy Jacobson

[email protected]

Security Level: Email, Account Authentication (Required)

Signature Adoption: Pre-selected Style

Signature ID:

B95A8DD6-DFB7-47E7-875F-2D30389AF738

Using IP Address: 128.147.28.61

With Signing Authentication via DocuSign password

With Signing Reasons (on each tab):

I approve this document

Sent: 7/23/2020 11:43:22 AM

Viewed: 7/23/2020 11:58:49 AM

Signed: 7/23/2020 12:00:38 PM

Electronic Record and Signature Disclosure: Accepted: 11/18/2019 10:29:41 AM ID: 84d2f0b8-77cd-44ed-870a-a7f2fe1744d8

Edward Livant

[email protected]


Signature Adoption: Uploaded Signature Image

Signature ID:

9E61B06A-1814-41D3-A698-FBE00AECF2FC





Sent: 7/23/2020 11:43:21 AM

Viewed: 7/23/2020 1:00:09 PM

Signed: 7/23/2020 1:00:40 PM

Electronic Record and Signature Disclosure: Accepted: 7/23/2020 1:00:09 PM ID: a3c997ca-1bda-4a4c-99ce-fd02ef9ba76f

Signer Events Signature TimestampGonasagrie Nair

[email protected]



Signature ID:

94CE584B-8B64-45AE-B8BC-186FCAA2622C





Sent: 7/23/2020 11:43:21 AM

Viewed: 7/24/2020 3:20:51 AM

Signed: 7/24/2020 3:40:13 AM

Electronic Record and Signature Disclosure: Accepted: 11/21/2019 2:10:59 AM ID: 0d97972c-8f71-41f2-8249-4531446f3269

Jennifer Schille

[email protected]

Jennifer Schille, CDM

Security Level: Email, Account Authentication (Required) Signature Adoption: Pre-selected Style

Signature ID:

DC7D5F52-A94B-47D4-B47A-C9B0B9692704





Sent: 7/23/2020 11:43:22 AM

Resent: 7/24/2020 9:38:45 AM

Viewed: 7/27/2020 10:57:36 AM

Signed: 7/27/2020 10:59:02 AM

Electronic Record and Signature Disclosure: Accepted: 1/13/2020 12:20:17 PM ID: 0b1669a6-be01-40f1-97d7-2d6ac36b4384

Katherine Bunge

[email protected]



Signature ID:

7ED1C5A6-8772-40FD-BBF8-2FFE3C69B1FA





Sent: 7/23/2020 11:43:22 AM

Resent: 7/24/2020 9:38:45 AM

Viewed: 7/24/2020 1:39:04 PM

Signed: 7/24/2020 1:39:22 PM

Electronic Record and Signature Disclosure: Accepted: 11/15/2019 2:50:55 PM ID: e92d1b54-e48b-4ca6-b4a1-c266a5b5dbe5

Morgan Garcia

[email protected]

Senior Clinical Research Manager

Family Health International Inc - Part 11



Signature ID:

3991C5E7-871D-4407-BA59-74DA54EF0078





Sent: 7/23/2020 11:43:22 AM

Viewed: 7/23/2020 11:45:18 AM

Signed: 7/23/2020 11:45:57 AM

Signer Events Signature TimestampElectronic Record and Signature Disclosure: Accepted: 11/6/2019 1:31:27 PM ID: 940f1278-9a35-4f6b-8526-9ebd7feabb8c

Sarah Roberts

[email protected]



Signature ID:

02C2DE11-72B0-4962-9E6F-687EFC33799B





Sent: 7/23/2020 11:43:23 AM

Viewed: 7/23/2020 1:52:40 PM

Signed: 7/23/2020 1:54:22 PM

Electronic Record and Signature Disclosure: Accepted: 1/10/2020 12:00:11 PM ID: 2134c07f-c42b-4538-9776-d51e9251a9d4

In Person Signer Events Signature Timestamp

Editor Delivery Events Status Timestamp

Agent Delivery Events Status Timestamp

Intermediary Delivery Events Status Timestamp

Certified Delivery Events Status Timestamp

Carbon Copy Events Status Timestamp

Witness Events Signature Timestamp

Notary Events Signature Timestamp

Envelope Summary Events Status TimestampsEnvelope Sent Hashed/Encrypted 7/24/2020 9:38:45 AM

Certified Delivered Security Checked 7/27/2020 10:57:36 AM

Signing Complete Security Checked 7/27/2020 10:59:02 AM

Completed Security Checked 7/27/2020 10:59:02 AM

Payment Events Status Timestamps

Electronic Record and Signature Disclosure

ELECTRONIC RECORD AND SIGNATURE DISCLOSURE

From time to time, Family Health International Inc - Part 11 (we, us or Company) may be

required by law to provide to you certain written notices or disclosures. Described below are the

terms and conditions for providing to you such notices and disclosures electronically through the

DocuSign system. Please read the information below carefully and thoroughly, and if you can

access this information electronically to your satisfaction and agree to this Electronic Record and

Signature Disclosure (ERSD), please confirm your agreement by selecting the check-box next to

‘I agree to use electronic records and signatures’ before clicking ‘CONTINUE’ within the

DocuSign system.

Getting paper copies

At any time, you may request from us a paper copy of any record provided or made available

electronically to you by us. You will have the ability to download and print documents we send

to you through the DocuSign system during and immediately after the signing session and, if you

elect to create a DocuSign account, you may access the documents for a limited period of time

(usually 30 days) after such documents are first sent to you. After such time, if you wish for us to

send you paper copies of any such documents from our office to you, you will be charged a

$0.00 per-page fee. You may request delivery of such paper copies from us by following the

procedure described below.

Withdrawing your consent

If you decide to receive notices and disclosures from us electronically, you may at any time

change your mind and tell us that thereafter you want to receive required notices and disclosures

only in paper format. How you must inform us of your decision to receive future notices and

disclosure in paper format and withdraw your consent to receive notices and disclosures

electronically is described below.

Consequences of changing your mind

If you elect to receive required notices and disclosures only in paper format, it will slow the

speed at which we can complete certain steps in transactions with you and delivering services to

you because we will need first to send the required notices or disclosures to you in paper format,

and then wait until we receive back from you your acknowledgment of your receipt of such

paper notices or disclosures. Further, you will no longer be able to use the DocuSign system to

receive required notices and consents electronically from us or to sign electronically documents

from us.

All notices and disclosures will be sent to you electronically

Electronic Record and Signature Disclosure created on: 11/6/2019 11:30:00 AMParties agreed to: Cindy Jacobson, Edward Livant, Gonasagrie Nair, Jennifer Schille, Katherine Bunge, Morgan Garcia, Sarah Roberts

Unless you tell us otherwise in accordance with the procedures described herein, we will provide

electronically to you through the DocuSign system all required notices, disclosures,

authorizations, acknowledgements, and other documents that are required to be provided or made

available to you during the course of our relationship with you. To reduce the chance of you

inadvertently not receiving any notice or disclosure, we prefer to provide all of the required

notices and disclosures to you by the same method and to the same address that you have given

us. Thus, you can receive all the disclosures and notices electronically or in paper format through

the paper mail delivery system. If you do not agree with this process, please let us know as

described below. Please also see the paragraph immediately above that describes the

consequences of your electing not to receive delivery of the notices and disclosures

electronically from us.

How to contact Family Health International Inc - Part 11:

You may contact us to let us know of your changes as to how we may contact you electronically,

to request paper copies of certain information from us, and to withdraw your prior consent to

receive notices and disclosures electronically as follows:

To contact us by email send messages to: [email protected]

To advise Family Health International Inc - Part 11 of your new email address

To let us know of a change in your email address where we should send notices and disclosures

electronically to you, you must send an email message to us at [email protected] and in

the body of such request you must state: your previous email address, your new email

address. We do not require any other information from you to change your email address.

If you created a DocuSign account, you may update it with your new email address through your

account preferences.

To request paper copies from Family Health International Inc - Part 11

To request delivery from us of paper copies of the notices and disclosures previously provided

by us to you electronically, you must send us an email to [email protected] and in the

body of such request you must state your email address, full name, mailing address, and

telephone number. We will bill you for any fees at that time, if any.

To withdraw your consent with Family Health International Inc - Part 11

To inform us that you no longer wish to receive future notices and disclosures in electronic

format you may:

i. decline to sign a document from within your signing session, and on the subsequent page,

select the check-box indicating you wish to withdraw your consent, or you may;

ii. send us an email to [email protected] and in the body of such request you must state

your email, full name, mailing address, and telephone number. We do not need any other

information from you to withdraw consent.. The consequences of your withdrawing consent for

online documents will be that transactions may take a longer time to process..

Required hardware and software

The minimum system requirements for using the DocuSign system may change over time. The

current system requirements are found here: https://support.docusign.com/guides/signer-guide-

signing-system-requirements.

Acknowledging your access and consent to receive and sign documents electronically

To confirm to us that you can access this information electronically, which will be similar to

other electronic notices and disclosures that we will provide to you, please confirm that you have

read this ERSD, and (i) that you are able to print on paper or electronically save this ERSD for

your future reference and access; or (ii) that you are able to email this ERSD to an email address

where you will be able to print on paper or save it for your future reference and access. Further,

if you consent to receiving notices and disclosures exclusively in electronic format as described

herein, then select the check-box next to ‘I agree to use electronic records and signatures’ before

clicking ‘CONTINUE’ within the DocuSign system.

By selecting the check-box next to ‘I agree to use electronic records and signatures’, you confirm

that:

You can access and read this Electronic Record and Signature Disclosure; and

You can print on paper this Electronic Record and Signature Disclosure, or save or send

this Electronic Record and Disclosure to a location where you can print it, for future

reference and access; and

Until or unless you notify Family Health International Inc - Part 11 as described above,

you consent to receive exclusively through electronic means all notices, disclosures,

authorizations, acknowledgements, and other documents that are required to be provided

or made available to you by Family Health International Inc - Part 11 during the course of

your relationship with Family Health International Inc - Part 11.

https://support.docusign.com/guides/signer-guide-signing-system-requirements

https://support.docusign.com/guides/signer-guide-signing-system-requirements

mtn-034 study-specific procedures manual overview and control document version … ·...

Documents