Mobile Behavioral Intervention to Reduce Maternal Drinking in South Africa
Phase: NA
Conditions: Maternal; Alcohol Use, Affecting Fetus
Sponsor: RTI International

1 
Maternal Alcohol Reduction Intervention in 
South Africa [MaRISA] 
Protocol Manual 
NCT05319977; March 10, 2021 

2 
 
Please note: The research proposal is for a National Institute of 
Health grant to be funded by NIAAA. The proposal has been 
selected for funding.  In keeping with the funding guidelines, after 
MRC ethics approval 

1 
 
CHAPTERS 
1. CHAPTER 1: INTRODUCTION 
2. CHAPTER 2: STAFFING & OPERATIONS 
3. CHAPTER 3: PROTECTION OF HUMAN SUBJECTS 
4. CHAPTER 4: QUALITY ASSURANCE & DATA MANAGEMENT 
5. CHAPTER 5: RECRUITMENT, SCREENING, INTAKE AND ALL STUDY 
APPOINTMENTS 
6. CHAPTER 6: DISTRESSED RESPONDENTS 
7. CHAPTER 7: INCIDENT REPORTING 
8. CHAPTER 8: ANNEXURES 
 
 

 
CHAPTER 1: INTRODUCTION 
 
SAMRC Investigators: 
Site Principal Investigator (contact PI); Co-Investigator 1 & Co-Investigator 2  
 
 
RTI International Investigators: 
Principal investigator; Co-Investigator 1 & Co-Investigator 2  
 
USA Consultants: 
Consultant 1: Biostatistician 
 
CHAPTER 2: STAFFING & OPERATIONS 
 
2.1. Introduction 
This chapter reviews what is expected from staff working on this research study. There will be 
a number of activities and tasks that staff will be expected to perform. Each of these roles 
include specific tasks and responsibilities that must be completed to a high standard.  This 
chapter will describe the core activities and functions of each role.  
 
All staff, regardless of level, are expected to represent a project that cares about people by 
always acting as role models and be kind to participants, other patients and healthcare staff. 
We encourage staff to show respect and be professional at all times while working on this 
study. Please note, we are guests in the healthcare facilities, therefore, it is critically important 
that we keep good relationships with all staff we engage with at the healthcare facility. 
 
 
 
 
 

 
 
2.2. Roles and Responsibilities of Staff 
2.2.1 Organogram 
 
2.2.2 Project Staffing 
There are a variety of staff working on this project.  
 
Project Coordinator: is responsible for assisting the Site-PI with all study related 
activities and co-ordination, including applications for approval to the Department of 
Health. They are responsible for overseeing day-to-day activities, ensuring that all 
study-related materials and incentives are available. They are responsible for data 
management and will provide support in the reproduction of study-related materials, 
and assist with literature searches, preparation of slides and other materials for 
reports, presentations, and publications. They are supervising all field workers, provide 
training to field workers on recruitment, data collection and tracking procedures.  They 
will conduct quality checking to ensure all data storage SOPs and data collection 
SOPs are being adhered to.  This will include collection of self-report and biological 
data.  They will be responsible for maintaining regulatory (GCP and ethics) oversight, 
maintenance and stock control of supplies.  
Principal 
Investigator
Data 
manager
Research 
Assistant
Site Principal 
Investigator 
Project 
Coordinator
Fieldworker 2
Fieldworker 1

 
 
 
Fieldworkers  
Will be based at the participating healthcare facilities and MOUs. They will be 
responsible for conducting screening to identify potential patients who are eligible to 
participate in the study, consenting eligible patients and enrolling them in the study, 
scheduling appointments, collecting contact information, conducting the baseline and 
follow up assessments and tracking participants for study appointments. All of these 
activities will require the completion of certain paperwork that will be explained in 
subsequent chapters of this manual. When conducting such activities, staff members 
must be very conscientious about checking the quality of their own work and ensuring 
that all interviews are completely and accurately documented using the appropriate 
forms. Fieldworkers will report directly to the Project Coordinator and indirectly to the 
Site PI.  
Fieldworkers Daily Tasks: 
• Maintain confidentiality at all times,  
• Be flexible with scheduling appointments (e.g., late afternoon appointments or 
weekend follow up appointments for assessments),  
• Check the quality of own work,  
• Check email accounts at least once daily, 
• Check project-device messages regularly throughout the day, 
• Maintain appointment book 
• Keep all supplies in a secure location, 
• Report any missing items immediately to the Project Coordinator and 
• Report all incidents to the Project Coordinator as described in the ‘Incident 
Reporting’ chapter. 
2.3. Staffing Operations 
2.3.1 Staff Dress-code  
All frontline staff for this study (including fieldworkers employed by the study) are 
expected to wear their MaRISA t-shirts when conducting research activities at the field 
site office, the healthcare facility and the communities. These t-shirts will be issued to 
staff. These t-shirts can preferably be worn with a pair of jeans or black pants and 
comfortable shoes. We expect all fieldworkers employed by the study to always look 
neat and professional.  

 
 
 
2.4. Project Sites 
MaRISA operational site will be based at the Delft offices. The study recruitment site 
will be based at two healthcare facilities, i.e., Bishop Lavis MOU, and Macassar MOU.  
The Delft office is situated in Delft, and are currently being shared with staff from other 
affiliated research studies. This section will provide detailed information on the safety 
procedures which should be followed at all our project sites, both our main site and at 
the health facilities, as well as protocols relating to the management and monitoring of 
petty cash and supplies.   
 
All research activities will be conducted at the following healthcare facilities: 
Health Facility / 
Clinic Name 
Facility Type  
Site Code 
Address  
1. Site A 
Community 
Health Centre 
M_BL 
MOU, Bishop Lavis, Cape 
Town 
2. Site B  
Community 
Health Clinic 
M_MC 
MOU, Macassar, Cape 
Town 
 
The research team will initiate contact with each health facility prior to conducting any 
formal research related activities. The facility and/or operational managers will initially 
be contacted to make logistical arrangements where research activities will be 
conducted for the duration of all study phases.  
 
2.5 
Safety Procedures at Project Sites 
2.5.1 Delft Offices (Field Site)  
In order to encourage the safety of staff and all assets situated at the Delft office we 
would like to promote the following safety measures to be taken on a daily basis: 
 
• Always ensure that the project site gates are kept locked. 
• Never allow anyone who looks suspicious to enter the site, rather talk to them 
through the security gate. 

 
 
• No expensive assets such as devices, computers, cameras, cell phones etc. 
should be left out overnight; please make sure that all assets are locked-up 
before leaving at the end of day. 
• Also ensure that all windows are closed, and air conditioners are switched off 
before leaving at the end of day. 
 
2.5.2 Health Facility Sites 
At each health facility there will be a security company contracted to ensure the safety 
of all employees and patients, as well as keeping the building including all the assets 
on the premises intact. Employees are encouraged to familiarize themselves with the 
security personnel at the facility and establish their role at the facility. Employees 
should also enquire from the facility manager or operational manager at the facility 
what safety protocols the facility has in place so that they are aware of these protocols. 
 
If you are concerned about a participant’s mental status prior to commencing a 
scheduled appointment discreetly communicate the matter with the Project 
Coordinator, to discuss whether the participant needs to be rescheduled for another 
day and/or referred to the Emergency Room or Mental Health Nurse on duty. 
 
When conducting case management activities, the following steps should be followed 
to ensure safety and security of assets: 
1) First contact the participant telephonically a day before making a home visit. 
2) During this call make an appointment with the participant for a specific day 
and time that you will be visiting them at their home, to ensure that they will be 
available. 
3)  Please 
note: 
NO 
FIELDWORKER 
SHOULD 
CONDUCT 
CASE 
MANAGEMENT / HOME VISITS ALONE – ALWAYS BE ACCOMPANIED 
BY ANOTHER STAFF MEMBER. 
4) If at any time you feel uncomfortable, unsafe or threatened, communicate this 
with your companion and return to the health facility immediately. If this occurs 
prior to reaching the participant’s home, then contact the participant when 
back at the health facility and explain the situation and try to reschedule 
another convenient time you can do a home visit.  

 
 
5) Except for the study cell phone don’t carry any other valuables with you when 
conducting home visits. 
 
**Please remember to report any incident in your incident report form, which 
must be filled in immediately or soon after the incident, sent to the Project 
Coordinator and Site PI via email/electronically, and kept on file at the field 
site (Delft Office). 
 
2.5.3  Engaging with Health Facilities 
After receiving an approval letter from the Department of Health indicating that you 
can continue with all research activities at a facility, communication should follow in a 
systematic manner. 
• 
Step 1 - Contact senior management (Facility Manager (FM), Operational 
Managers (OPMs) & Fam. Physician) via email to introduce the study, provide 
them with the approval letter and schedule an appointment for research 
purposes / a visit. 
• 
Step 2 -  Always follow-up a day or two later telephonically if you didn't receive 
response via email; if you have received response the telephonic follow-up 
should still occur to confirm details of appointment. 
• 
Step 3 - Prior to going to the facility follow-up a day before, telephonically or via 
email to remind management that you will be coming to the facility to conduct 
research activities / a visit etc. 
• 
Step 4 -  On the day of the appointment (depending on the visit), on arrival at 
the facility always first go to the FM or OPM to greet them and inform them that 
you are at the facility for the day and also provide them again with a hard-copy 
of the approval letter if it's the first day or first time you come to the facility.  
2.6 
Protocol for Petty Cash 
 
The SAMRC will advance petty cash to the Project Coordinator, amounts of which will 
be determined by the needs of the project. Requests for petty cash must be submitted 
to the SAMRC through the JDE financial system at least one month in advance to 
ensure money will be available to reimburse participant’s transport fees. 
 

 
 
Prior to the initiation of recruitment procedures, each field worker will be issued a 
specific calculated amount by the Project Coordinator to reimburse participant’s 
transport fees. The fieldworker will sign a receipt documenting they acknowledge 
receipt of the money and that they will be held responsible if the participant does not 
receive their reimbursement. It will also be the fieldworker’s responsibility to make sure 
the participant signs the receipt book when issued with the transport fee. Transport 
fee will be issued only at study required appointments, i.e. when participants need to 
visit the healthcare facility for urine monitoring or if the baseline appointment is 
scheduled on a different day than the screening appointment. The petty cash received 
needs to be locked up in a lockable petty cash box, which will be kept in a double 
lockable steel cabinet, and only the fieldworker and Project Coordinator should have 
access in the form of keys to both the petty cash box and the cabinet. Under no 
circumstances should the petty cash box be left out unlocked and unattended 
during the day or be left out overnight.  
     
2.7 
Supplies 
 
Please note: All hard-copy forms will be printed and available prior to data collection 
activities. All other necessary materials will be arranged as needed.  
 
The fieldworker will be responsible for all assets and supplies issued to them at the 
start of the study. If for any reason they foresee there will be a shortage of 
documents or supplies, it is their responsibility to inform the Project Coordinator in a 
reasonable timeframe. If this does not occur, procurement of supplies will 
unfortunately take longer to obtain which will have a detrimental effect on the daily 
functionality of the study.  
 

 
 
CHAPTER 3: PROTECTION OF HUMAN 
SUBJECTS 
 
3 Introduction 
Protecting the rights and confidentiality of the participants in the MaRISA study is of 
utmost importance. This chapter will briefly review participants’ rights and the 
commitments to participants that all staff must make, data security issues, and 
professional ethics. 
 
2.1. Ensuring Participants’ Rights, Privacy, and Confidentiality  
 
3.1.1 Participants’ Rights 
Basic human rights must be respected and maintained by a research organization and 
all who are involved in its activities.  The protection of rights and confidentiality has 
always been especially critical in studies focused on substance use, where exposure 
of past or current abuse or addiction can have social, economic, and legal 
consequences. MaRISA’s research procedures are designed to protect individual 
rights and to comply with all applicable laws and ethical principles.  Among the rights 
that must be protected are:   
 The right to accurate representation: 
o Requires honesty in dealing with participants and provision of 
completely accurate information about the study. 
 The right of informed consent: 
o Requires that a participant be given adequate information to 
make an informed decision about participation. 
 The right to refuse: 
o Requires that an individual be fully informed of his/her right to 
decline to participate, to withdraw, or to refuse to answer any 
question.  
 The right of privacy:  
o Requires guarantees against invasion of privacy as well as 
specific protection as specified in the South African Protection of 
Personal Information Act of 2013.   

 
 
These rights are extremely important to us as individuals and as professionals 
engaged in applied research.  All SAMRC studies must develop specific written plans 
for conducting research with human subjects.  Research staff must also operate under 
the supervision of committees for the protection of human subjects to ensure that they 
do not violate these rights.  
 
In research involving follow-ups and contacts, it is necessary to collect names, 
addresses, and other personal information from participants for future follow-ups.  A 
great deal of information collected from participants pose a risk to participants, 
especially if their use of substances is not known to others.  It is extremely important 
that the data collected be kept confidential.  
 
3.1.2 Project Staff Commitment 
 
The staff member collecting data directly from a participant presents perhaps the 
greatest risk to a participant's privacy.  As in all our research, we are very concerned 
about this risk and take several steps to ensure that problems do not occur.  All project 
staff are required to sign the MaRISA Staff Agreement of Confidentiality form, 
depending on their project roles and responsibilities. These pledges serve to reinforce 
the seriousness of this aspect of the study. The confidentiality agreement states that 
project staff members are prohibited from revealing information obtained from study 
participants. The agreement also states the consequences for staff revealing this 
information. 
 
 
 

 
CHAPTER 4: QUALITY ASSURANCE & DATA 
MANAGEMENT 
 
3. Introduction 
 
It is really important that we collect the correct data (information), in the correct 
way. In this chapter, we will describe the types of data that we are collecting, give 
you tips on how to collect good data and also how to correct data which has been 
collected in error.  
Data will be held in a confidential and secure manner as outlined in the Data 
Management Plan. All data will be entered into REDCap, a password-protected 
data collection and management system that will have built-in checks for 
consistency and completeness. Electronic data entered in REDCap will be 
downloaded to the internal RTI project share weekly. All data are kept on 
password-protected servers. The PI and Data Manager will be responsible for 
reviewing and cleaning the data and preparing weekly reports during data 
collection, with assistance and guidance from RTI Co-Is. All data, including forms 
with personally identifiable information (PII) such as locator forms and consent 
forms, will be kept on password-protected servers. South African investigators and 
staff will have full access to the data. All collected hard-copy data will be stored in 
double-locked steel cabinets only accessible by the Site-PI, Project Coordinator 
and the two fieldworkers. All data will be scanned and uploaded to REDCap for 
ease of access and data analysis purposes. 
Data Quality Control (QC) and Quality Assurance (QA) 
Quality assurance systems will be put in place to ensure that the data are cleaned 
and accurately transmitted, organized, and properly managed. With participants’ 
permission, the Site-PI/Project Coordinator will observe remotely 20% of baseline 
and follow-up appointments and will document feedback. 
 

 
 
Correction Process 
Once an issue has been identified in the QA or QC findings, it will be discussed at 
the weekly site check-in meetings. The root cause of a recurrent problem will be 
identified, and follow-up actions will be taken to correct the problem based on the 
input from the RTI and SAMRC staff. These actions may include but are not limited 
to, changing a process or revisions of project forms, training, or reassignments of 
tasks. For more serious issues such as protocol violations and breach of project 
participant confidentiality, the Co-Is will be notified immediately and will work with 
the field staff to ensure that corrective actions are taken in a timely manner. Based 
on the severity of the issues identified, the PIs will immediately report the issue to 
the PO, DSMB Chair and institutional review board of record (SAMRC Ethics 
Committee), who will determine further recommendations. 
Table 1: Corrective Action Reporting Process 
Step 
Description 
Responsible Person 
1  
Identify the issue (protocol violation, breach of 
confidentiality, data issue (such as entry, missing etc.)) 
Project Coordinator 
and Fieldworkers 
2 
Report oversight, error or issue to PI or Co-Investigator 
(Co-I) 
Project Coordinator 
3  
Recognize impact of issue 
PIs 
4 
Investigate cause 
PIs 
5 
Recommend corrective action 
PIs 
6 
Implement corrective action 
All staff 
7 
Notify PO, DSMB Chair and SAMRC Ethics Committee 
within 48 hours as needed. 
PIs 
 
 

 
 
Potential Improvements 
Identifying and implementing potential improvement of project protocols will be an 
ongoing process that will be integrated into the routine planning, management, and 
implementation project processes. It is the responsibility and standard practice of 
all project staff to identify and appropriately communicate opportunities for quality 
improvement to the PIs. These improvements will be documented, and ethics 
approvals will be included in the yearly progress reports. 
 
3.1.  Data collection issues and solutions 
Here are a few common issues that may come up during data collection or during a 
session: 
• At the beginning of the assessment, remind the participant how long the 
assessment will take to complete.  Make sure they can stay for that length of time 
it takes to complete the assessment.  Do not begin the assessment if they cannot 
stay for the entire time it will take- rather reschedule the appointment. 
• If you see that a participant is confused about a question or task, stop and ask 
them if they understand. If you are still not sure if they understand or not, ask 
them to explain the question to you in their own words. 
• If a participant says one thing for one question, and then answers completely 
differently for another question on the same topic, stop and try to see if the person 
has understood you. If necessary, go back to the previous question and check 
their answer. 
• At certain times, participants may become less willing to answer questions, or 
they may seem to just be giving you any answer to finish quickly. Stop the 
interview and ask the participant if they are alright. Sometimes this is because a 
participant is upset about something. Sometimes the person is in a rush to leave, 
or they are hungry or thirsty. Ask them if they would like a break to eat their 
snacks, take medication or use the bathroom. Let them know how much longer 
the session will be.  
• If at any time you are worried that a participant is not well, alert the medical staff 
straight away. The participant’s medical care is not your responsibility at all. Ask 

 
 
for help if you are concerned. The following symptoms or signs in participants 
should be reported:  
a. feeling faint or dizzy 
b. complaining of pain, especially chest pain or a severe headache 
c. sudden weakness 
d. slurred speech  
e. confusion and becomes unable to understand the questions. 
f. any type of sudden bleeding or going into labor 
g. anything else that worries you. 
 
3.2. Entering data on REDCap and filling in paper forms 
Data Entry on REDCap Mobile App 
- 
Ensure that the project has been downloaded to the tablets prior to data collection. 
This may take some time and requires an internet connection. 
- 
After downloading the project, click Collect Data. Select an instrument and click 
"Create Record" to create a new record or click on an existing record and enter 
data as usual (following questionnaire flow). Check that each record has been 
saved and completed. All collected data must be sent to the server at the end of 
the day. Uploading data requires internet connection. Click "Send Data to Server" 
and then click “Begin Send button” to send data.  
- 
 Before turning off the tablet, please ensure that the data upload is complete. If an 
error occurs, please email Data Manager for further instructions. 
- 
To ensure that project modifications are current in the app, click "Refresh Setup 
and Data." This will erase all previous data from the tablet and replace it with 
everything from the REDCap online server. ((** THIS SHOULD ONLY BE DONE 
AFTER ALL DATA HAVE BEEN SENT TO THE REDCAP ONLINE SERVER, 
OTHERWISE ALL DATA COLLECTED ON THE TABLET WILL BE DELETED**)). 
 
If entering data directly on REDCap database 
Each fieldworker will use their own username/password or assigned username and 
password while utilizing REDCap. When entering data, double check Records for 
duplicates and ensure all forms are completed. 
 

 
 
3.3. Submitting collected field data 
Should you need to use paper forms to ask the screening questions, baseline or follow-
up assessments, you should submit these to the Project Coordinator at the first 
opportunity. We ask that you fill in the date of the data collection, date when you 
submitted the forms and which data was collected (screener, baseline assessment, 
etc.). 
3.4. Receiving data queries 
Sometimes you will receive a message from the Data Manager, asking about a certain 
participant or a certain question. This happens in every study, so do not be worried. 
This may be easy for you to answer straight away, such as giving the correct spelling 
of a name, or you may need to contact the person (by phone or in person) to verify the 
information. We need to make sure that all our data are accurate. 
3.5. Keeping data safe  
All the data we collect for MaRISA, whether digitally (on REDCap) or on hard copies, 
should be kept safe at all times. Our data include participants’ phone numbers, locator 
information, details of their physical health or that of their babies, consent forms and 
any other information we collect as part of the study. 
3.5.1. 
Maintaining participant confidentiality 
MaRISA data should not be shown to anyone outside of MaRISA. In the same way, 
none of us should talk about any of the data with anyone not involved in MaRISA, 
including the clinic/healthcare staff. This is called maintaining participant 
confidentiality. Each of us will sign a confidentiality agreement before we start the 
study. Should the clinic staff, a participant’s family member or another participant ask 
you for any information on a study participant, advise them that you may not give them 
this information as it is confidential. Clinic staff may know that a participant is part of 
the study, but beyond that we will not be sharing any study details with them. Should 
they keep asking, please give them the telephone numbers of the Project Coordinator 
or Site PI to further discuss the matter with them. 
3.5.2. 
Storing our data safely 
Once we have collected the data, all the data should be stored safely.  

 
 
The participant folders should be kept locked away in the filing cabinet, even if you are 
still busy at the clinic/healthcare facility. You should only have the folders out that you 
are busy with, and you should never go and have tea, or walk away, leaving any 
folders, supplies or valuables outside the cabinet. This also applies to any other forms 
or papers related to MaRISA. If you are not busy on the tablet, please also keep it in 
the locked cabinet and leave the tablet in the filing cabinet at the end of your shift. 
Remember: Any hardcopy forms with patient names or contact details 
will be stored in the CONTACT folder.  All other hardcopy forms will go 
into the EVERYDAY folder. Each of these files will be kept in separate 
drawers in the stainless-steel cabinets. 
 
 
 
 

 
 
CHAPTER 5: STUDY PROCEDURES 
 
4. Introduction and Expectations 
Staff should keep in mind that they are patients’ first contact with the project. In 
doing so, the team gives patients their first impression of the project.  
 
How you approach people, your body language, dress code, attitude and what you 
say will leave a lasting impression on people who are screened for the study and 
others. These impressions can influence whether people will want to participate or not 
in the study. Be conscious of the impressions you make and be careful of what you 
say – try and make people feel comfortable and welcome.  
 
For the pilot testing phase, we aim to recruit 60 (30 pregnant and 30 post-partum) 
women for the two healthcare facilities. Both the pregnant and post-partum women 
need to report that they are using alcohol. Fieldworkers will conduct the baseline 
assessment, 6-week follow-up assessment, and the 3month follow-up assessment. 
 
5.1 
Pilot: Recruitment Procedure  
Much of the success of screening potential study participants will result from exercising 
good judgment and maintaining sensitivity toward the people you speak to. Staff 
members who have been chosen to work on MaRISA have two important qualities: 
(1) They are capable of working in the healthcare facility and know the 
surrounding community, and 
(2) They have good instincts as to the best ways to get a response from 
potential participants. Rely on these instincts but remember that a degree of 
assertiveness is essential to doing the job well. 
 
It is important to recruit women into the study who seem interested and have a notable 
level of readiness to change, as perceived by the potential participant’s verbal and 
nonverbal communication. Recruiting interested and motivated women into the study 
increases the likelihood that they will be engaged and committed to completing all 
steps of the study. We want participants who are willing and able to come to all 

 
 
their appointments. It is therefore important to check whether they have the time and 
ability to commit to being in the study for the duration of the study.  
 
If people hesitate or do not seem that interested, do not put pressure on them to take 
part! If we recruit people who are not committed to being in the study throughout the 
whole process, this will negatively affect our follow-up rate.  
 
Additionally, during the screening and consenting process, project staff members have 
the opportunity to determine whether participants are mentally capable of participating 
in the study, particularly during the consent process (which will be further explained 
below). 
 
If potential participants cannot say in their own words what the 
study is asking of them during the consent process, they should 
not be enrolled into the study. 
 
 5.2. Screening 
Once introductions are made and a patient’s cooperation has been secured, complete 
the participant ID, staff ID, site and date fields on the screener, using the tablet.  
• For the pilot phase, we will be using the “Pilot Screener for Pregnant and Post-
Partum Women” at the onset of the pilot phase.  
 
Recruitment will be done via clinic referrals, posters, and flyers.  
 
Participant IDs will be according to the following format, it will consist of ten 
digits with both alphabetic and numerical items, e.g., M_BL0001PR or 
M_BL0001PP. 
Please note: the first alphabetic digit refers to the MaRISA study, an underscore 
sign separates it from the next 2 alphabetic digits which indicates the site, e.g., 
Bishop Lavis = M_BL, the next 4 digits indicates how many participants have 
been enrolled into the study and the last 2 digits indicates whether the 
participant is currently pregnant or post-partum.    
 

 
 
There are types of potentially sensitive information that are requested on the screening 
questionnaire. It is important to stress the confidential nature of the screener. 
Reassure them that their identity will never be linked to their responses and that their 
responses are only used for research purposes. Always remind individuals that their 
answers will be kept strictly confidential. 
 
Staff ID#: Will be a staff member’s Initials. 
Site ID#: Bishop Lavis = M_BL; Macassar = 002 
 
To be eligible, women must fulfil in the following criteria, i.e.: 
Criterion 
Participants 
Age 
Be ≥18 
Pregnancy or Post-Partum Status 
be pregnant (≤28 ges wks) or postpartum 
(≤3 mos) 
Alcohol Use 
• 
have reported alcohol use during the 
current pregnancy or lactation  
• 
test positive for alcohol use by 
urinalysis (i.e., EtG) 
Birth Venue (linked to birth outcomes) 
plan to complete antenatal care at the 
current clinic and remain in the area for at 
least 3 months 
Cellphone Status 
own a cell phone to receive text messages 
Serious Medical Conditions and Suicidal 
Thoughts 
women who report serious medical 
problems threatening their current 
pregnancy or report current suicidal 
thoughts or attempts in the past month are 
NOT eligible 
Other 
intend to breastfeed for 6 months 
 
Women who participated in KIIs (the formative phase) or pretesting will not be eligible 
for pilot testing. Women who reported serious medical problems threatening their 
current pregnancy or current suicidal thoughts or attempts in the past month will not 
be eligible and will be provided with necessary referrals. 
 
Table 1: Possible dispositions for not participating or not continuing with participation. 
DISPOSITIONS 
 
Dispositions based off 
screening questions 
 
Dispositions before or after 
screening 
2.01 
Age <18 years old 
3.01 
Not interested ( before screening) 
2.02 
ETG tested negative 
3.02 
No time 

 
 
 
Screening, consenting and baseline and follow-up assessments will be conducted 
electronically via REDCap. Following consent, we will collect detailed contact 
information and schedule women for a baseline assessment. 
 
5.2.1. Alcohol Biological Testing 
Please follow the next steps when collecting biological samples. 
1. Provide participant with a urine cup to collect a urine sample as part of the 
screening process. 
2. Check the expiration dates when preparing the test.  
3. Make sure you have a marker to label the test with the participant’s study ID 
before you start the testing. 
 
Remember, willingness to be tested for alcohol is a requirement for study 
participation. If a participant has difficulty to pass urine, encourage them to drink 
some water or juice continue with explanations or completing other forms and to 
provide the urine sample a bit later. Giving the participant a drink before she starts 
the appointment will also be helpful.   
 
TEST INSTRUCTIONS 
For this study, we will be using an EtG urine test to determine if someone has 
alcohol in their body.  EtG stands for ethyl glucuronide, which is a substance 
produced in the liver when your body processes alcohol. EtG remains present in the 
body for about one to five days after drinking, depending on how much alcohol a 
person has drank, using small strips that are dipped in urine. Please use gloves 
before, during and while cleaning up after the biological testing process. Please 
conduct the testing as per the steps indicated. 
2.03 
Refused bio-sample 
3.03 
eligible, but not interested or 
refused 
2.04 
Over 28 weeks preg. 
3.04 
no reason given 
2.05 
Over 3 month postpartum 
3.05 
other 
2.06 
No alcohol use in current 
pregnancy or postpartum 
 
 

 
 
 
Record results on MaRISA Specimen Collection Log. 
 
CLEANING AFTER TESTING  
Make sure everything is thrown away appropriately after you have completed all 
biological testing. Everything used for the testing such as the tray must be wiped down 
with sanitizer or wipes after conducting biological tests.  
 
5.3. Baseline Assessment  
Remind the participant of their rights to confidentiality and privacy in answering the 
questions with the exception if they indicate desire to harm themselves or someone 
else.  Refer to the Distressed Participant Procedures (see Chapter 6) if a patient ever 
indicates they will do harm to themselves or someone else.  If the participant has any 
questions or concerns about being in the study, they can contact the Site PI. Her 
contact information is on the Information and Consent Form. 
 

 
 
Baseline assessment questions will be conducted via CASI on a tablet. Assessment 
questions will cover sociodemographic factors; social determinants; recent and 
lifetime polysubstance and alcohol use; IPV/GBV exposure; partner drinking; stigma; 
coping with stress; and reproductive, sexual, physical, and mental health.  
 
5.4. Follow-up Appointments and reimbursements 
The participant will be reimbursed for their transport costs based on the following 
scale.  Transport costs should only be reimbursed if the participant has needed to 
travel to come to the healthcare facility for a study appointment: 
Categories of distances 
Amount provided 
0km – 3km 
R10 
4km – 10km 
R30 
11km + 
R50 
 
 
Pilot Phase: 
In addition to monitoring participants’ through urinalysis twice a week, participants will 
be asked to participate in the 6-week and 3-month follow-up assessments at the 
healthcare facility they were enrolled at.  
A participant will be provided R150.00 each at baseline and follow-up assessments. 
 
Consent will be obtained to collect participants’ birthing facility information for those 
who were recruited during pregnancy to track birth outcomes. If a participant is already 
postpartum and breastfeeding, self-reported incidents of breastfeeding while using 
alcohol will be collected. Infants’ data relating to their height, weight, and head 
circumference will be collected.  
 
If a participant misses a visit, we will contact the participant following a standard 
protocol (i.e., phone call on the appointment day, the following day, and 1 week after 
the missed visit to encourage rescheduling for the missed appointment). Participant 
locator information will also be updated at each appointment. Staff members need to 

 
 
prioritize tracking participants who have the least number of days left before their 
upcoming appointment so that they do not time out of the study. In other words, you 
should contact participants first whose next appointment is closest to the current 
date.  
If a participant has withdrawn from the study or has reported the loss of her 
foetus/baby to field staff and this was reported to Project Coordinator, the participant 
should not be tracked any longer. These participants will also not be replaced in the 
study since they have been reported on. 
 
5.6 
Creating Participant Folders 
The fieldworker needs to be aware of the hard-copy documents which each of these 
folders will consist of so that if any hard-copy forms are missing from a folder or 
more hard-copy forms are needed they would be able to identify which forms are left 
out or are needed.  
 
The fieldworker will be required to allocate a participant ID number to each of the 
folders and hard-copy forms by means of a participant ID sticker.     
5.6.1. Participant EVERYDAY Folders  
The EVERYDAY folder will contain all non-identifying hard-copy forms, i.e.: 
 Participant Screener (hard copy available in English, IsiXhosa and Afrikaans) 
 Baseline Assessment (hard copy available in English, IsiXhosa and Afrikaans) 
 Appointment Cards 
 Follow-Up Assessments (hard copy available in English, IsiXhosa and 
Afrikaans) 
 Fetal/Birth/Neonatal Outcomes Form 
 
Information and materials which will be included in the EVERYDAY folder and may 
possibly be given to the participant at the end of the first appointment: 
 Referral Guide Hand-out 
 MaRISA Contacts & Rights Cards (available in English, Afrikaans and 
IsiXhosa) 
 MaRISA Appointment Cards (one for each consecutive appointment) 
 

 
 
5.6.2. Participant CONTACT Folders  
The CONTACT folder will contain all identifying hard-copy forms, i.e.: 
 
 Information and Consent Form (available in English, IsiXhosa and Afrikaans) 
 Contact Information Form (hard copy) 
 MaRISA Specimen Collection Log 
 Participant Locator Form (hard copy) 
 Referral Form (hard copy) 
 And/or any other document containing identifying information e.g., copies of 
receipts for transport fee received; etc.  
 
 
 

 
 
CHAPTER 6: DISTRESSED RESPONDENTS 
 
6.1 Introduction 
Given the nature of this study, there may be instances, where you are faced with a 
distressed participant who you are concerned needs additional mental health support. 
For the most part, you can address this by talking to the participant and providing them 
with a referral to see the mental health nurse or for additional substance abuse 
services. 
6.1. 
What is a distressed participant? 
By “distressed” we mean that a participant shows signs of experiencing negative 
emotions and by her words, expressions, or other nonverbal behaviors or body 
language indicates that she is emotionally upset.   
 
Possible signs or indications of distress: 
• A participant who is tearful and/or reports that she feels badly or is sad. 
• A participant who shows signs of being considerably more nervous or anxious 
(e.g., very nervous speech, increased sweating, difficulty sitting still during the 
appointment) than would be expected during an appointment. 
• A participant who seems agitated or aggressive and that you cannot easily calm 
down. 
6.1.1. Steps to follow with mildly distressed participants who need additional 
services. 
In most cases of distress, participants may talk about feeling badly but you will be able 
to manage or contain these feelings and continue with the appointment.  They may, 
however, need additional services or support once all study appointments have been 
completed.   
In these cases, complete the following steps at the end of the study appointment: 
• Indicate to the person that they seem upset or anxious. 
• Discuss with the participant the importance of additional support. 
• Ask if they would like to receive additional services to talk more about feelings 
that came up during the course of the study. 

 
 
• If the participant indicates she would like to talk with someone further, ask if 
they would like you to refer them to an organization. 
• Complete the referral and release form. 
• With the patient’s permission, call the agency or the mental health nurse to 
make an appointment. 
• Provide the patient with a copy of the referral letter in an envelope and keep 
one in the CONTACTS folder. 
• Provide the patient with a copy of our resource guide for additional services. 
• If the participant indicates that she does not want you to make a direct referral, 
suggest various organizations for her to contact on her own and give them a 
copy of the resource guide.  
These steps should only be followed if the participant shows signs of distress or 
expresses a need for further support - but no suicidal intent or imminent harm is 
disclosed or suspected.   
If the person expresses any desire to end their life or hurt themselves or others, follow 
the steps described in 6.2. 
6.1.2. Steps to follow with very distressed participants. 
There may be instances where participants are so distressed that you are concerned 
for their safety and may not be able to continue with the appointment. Remember that 
we have made it clear in the consent form that there are exceptions to our promise of 
confidentiality. If participants express the intent to harm themselves or others, or 
ongoing abuse and/or neglect of children, then we have a duty to report this matter to 
the proper authorities, e.g., the police, courts or social workers. Field staff will provide 
information on toll-free hotlines that people can call to talk to someone and seek 
assistance, as well as local resource information.  
If during the study you are concerned that a participant intends to harm herself or 
others, then mandatory reporting procedures need to be followed on completion of the 
appointment. Immediately inform the Project Coordinator and the Site PI, who will 
report the mandatory reporting incidents to the ethics committee and our project officer 
within 72 hours.     

 
 
In these instances, please follow the following steps: 
• As far as possible, complete the study appointment. 
• Indicate to the person that they seem upset or anxious. 
• If they are expressing a desire to end their life (suicide), explore further whether 
this is an expression of distress or whether they have a) had previous attempts, 
b) have a plan to end their life. 
• If there is immediacy and a plan for suicide, remind the person of the limits of 
confidentiality as expressed in the consent form, and your duty to report. 
• Follow the mandatory reporting procedures described below. 
• Complete the referral and release form  
• Call the the mental health nurse to make an immediate appointment or 
accompany the participant to the ER section of the healthcare facility. 
• Provide the patients with a copy of the referral letter in an envelope and keep 
one in the CONTACTS folder. 
• Provide the patient with a copy of our resource guide for additional services. 
• Follow the reporting procedures in Chapter 7- complete an incident report form 
and immediately send to the Project Coordinator and Site PI who will both keep 
copies on file. 
 
6.2. Mandatory reporting procedures 
It is possible that a participant will indicate during the course of a discussion that she 
is in immediate danger of harm or poses a threat to the safety of others. We want 
you to feel that you can handle this situation with confidence.  
There are essentially three situations in which there may be immediate danger of 
harm: 
1) Suicidal Intent: The participant expresses a desire to hurt or kill themselves. 
2) Hurtful Intent to Others: The participant expresses an interest in hurting or 
killing someone else (not necessarily someone living in the household).  
3) Child Abuse and Neglect: Ongoing abuse and/or neglect of children. 

 
 
For each of these cases, you must follow compulsory or mandatory reporting 
procedures.  
These procedures are important to follow because they take away the responsibility 
of you having to decide what to do. These procedures are in your best interest and in 
the best interest of the participant- they are there to keep the participant safe and 
unharmed.  
6.2.1. Suicidal Intent 
If a participant expresses an interest in harming or killing herself, assess whether the 
risk is immediate or not immediate.  
Assessing immediacy of risk for suicide: Assessing risk for suicide involves 
exploring whether the person has current suicidal thoughts, a plan for suicide and 
access to means. Assess the risk asking the following questions: 
 
In The 
Past 
Month 
Answer Questions 1 and 2 
YES 
NO 
1) Have you wished you were dead or wished you could go 
to sleep and not wake up? 
 
 
2) Have you actually had any thoughts about killing 
yourself?  
 
 
If YES to 2, answer questions 3, 4, 5, and 6.  If NO to 2, go directly to 
question 6 
3) Have you thought about how you might do this?  
 
 
4) Have you had any intention of acting on these thoughts 
of killing yourself, as opposed to you have the thoughts 
but you definitely w ould not act on them?  
 
 
5) Have you started to work out or worked out the details of 
how to kill yourself?  
Do you intend to carry out this plan?  
 
 

 
 
 
In The 
Past 
Month 
 
In the 
Past 3 
Months 
6) Have you done anything, started to do anything, or 
prepared to do anything to end your life? 
 
Examples: Collected pills, obtained a gun, gave away valuables, 
wrote a will or suicide note, took out pills but didn’t swallow any, 
held a gun but changed your mind or it was grabbed from your 
hand, went to the roof but didn’t jump; or actually took pills, 
tried to shoot yourself, cut yourself, tried to hang yourself, etc. 
 
In your entire lifetime, how many times have you done 
any of these things? 
 
 
 
 
If the person answers YES to either questions 4, 5, or 6, this is a red flag, and you 
should consider them at high risk for suicide.  Risk is not immediate if the person is 
expressing some suicidal thoughts to describe how badly they feel but they do not 
have a plan.   
Note: A suicide plan or preparation for death, such as saying goodbyes and 
putting affairs in order, indicates serious suicidal intent! 
6.2.1.1. 
Procedure: NO IMMEDIATE RISK 
If it is clear to you that the participant poses no immediate risk to herself (i.e., the 
participant is not currently suicidal, but alluded to self-harm for some other reason, for 
example, to express how difficult their life circumstances are), then you should do the 
following: 
a) Complete the appointment,  
b) Remind participant of limits to confidentiality from the “Participant Information and 
Consent Form” and discuss seeking help by contacting LifeLine, SADAG or the 
Mental Health Nurse, 

 
 
c) After following these steps, you should complete an incident report form and report 
the incident to the Project Coordinator. Chapter 7 describes the reporting process 
in more detail. 
6.2.1.2. 
Procedure: IMMEDIATE RISK 
If you assess that the participant is at immediate risk to herself, read the following 
script to the participant: 
 
Script: Risk of participant suicide or self-injury (immediate danger of harm)  
 
Team member reads: 
  
“When you agreed to participate in this study, I promised that I would tell someone 
what you told me only if it was necessary to protect you or other people.  You told me 
earlier that you were thinking of harming yourself.  I suggest we contact an 
organization called LifeLine or SADAG and let them know so they can talk to you about 
how you feel. LifeLine and SADAG offers counseling. You can discuss your problem 
with one of their counsellors and they may be able to help you. Do you want to call 
them, or should I call them for you?” 
 
Willing participant: 
• If the participant agrees to contact Lifeline or SADAG, use the project phone to 
make the call for the participant, hand them the phone and go to another room 
to give them privacy during the call.  
• If the participant asks you to make the call on their behalf, use the project phone 
to make the call for the participant, hand the phone to the participant and go to 
another room to give them privacy in the call. 
Unwilling participant 
• If the participant is unwilling to contact the crisis hotline and doesn’t want you 
to contact them, then you should immediately contact the Project 
Coordinator/Site PI, who can assess the situation (e.g., determine reasons why 
the participant is unwilling to contact the hotline so these issues can be 
addressed) and who can contact one of the psychologists in the investigative 
team for further inputs.  

 
 
• You can also contact the family physician and/or mental health nurse at the 
facility for their guidance.  
• In the meantime, do not leave the participant by herself nor let them leave on 
their own, as they pose a risk to themselves.  
• Ask the participant if she has a close family member or friend who can come to 
sit with them until you receive clear instructions about what to do.  
• If the participant remains unwilling to contact the hotline, provide the participant 
with the referral guide as well as the counselling hotline numbers. 
• Make sure you document who you spoke to, and the advice provided on the 
incident form (see Chapter 7) 
 
6.2.2. Hurtful Intent to Others 
It is extremely unlikely, but someone may spontaneously tell you that they are planning 
to seriously hurt or kill someone else. If a participant expresses an interest in harming 
or killing someone else, you should take the following steps. 
• As far as possible, complete the study appointment. 
• Indicate to the person that they seem upset.  
• If they are expressing a desire to hurt someone else, explore whether there is 
an immediate risk (i.e., they have a plan and the means to do it).  
• If there is immediacy and a plan, remind the person of the limits of confidentiality 
as expressed in the consent form, and your duty to report. 
• Follow the mandatory reporting procedures described in Chapter 7. 
• Complete an incident report form and immediately send to the Project 
Coordinator and Site PI who will both keep copies on file. 
 
6.2.2.1. 
NO IMMEDIATE RISK 
If no immediate danger is perceived, advise the Project Coordinator and the Site PI 
immediately who will evaluate the seriousness of the issue and give advice on what to 
do. If the danger of harm is definitely credible, then the authorities will be called to 
report the incident. If the danger of harm is believed to definitely be credible, you may 
be advised to contact the police.  
 

 
 
6.2.2.2. 
IMMEDIATE RISK 
If immediate danger is perceived, please alert the Project Coordinator and the Site PI 
immediately and they will report the incident to the authorities. Do not let the 
participant leave before you have instructions from the police as to the next steps to 
take. Please follow each of these steps.  If you feel in danger, please follow the 
safety procedures outlined in the manual and ask for the assistance of the clinic’s 
security personnel. 
It is highly unlikely that you will be faced with this situation! 
 
6.2.3. Child Abuse/Neglect 
It is extremely unlikely, but someone may tell you that s/he has abused or neglected 
a child. If a participant reports this, you must report the incident to the police (if 
sexual abuse), or Childline (if any other type of abuse) after completing the 
appointment.  
Follow these steps: 
• As far as possible, complete the study appointment. 
• Indicate to the person that they seem upset.  
• If they are reported abusing a child, remind the person of the limits of 
confidentiality as expressed in the consent form, and your duty to report. 
• Follow the reporting procedures in Chapter 7- complete an incident report 
form and immediately send to the Project Coordinator and Site PI who will 
both keep copies on file. 
 

 
CHAPTER 7: INCIDENT REPORTING 
 
7. Introduction 
This chapter will outline the various types of reporting that may take place, and under 
which circumstances they should occur. 
 
Although the proposed study presents no greater than minimal risk to participants, 
adequate provisions to mitigate these risks will be outlined further in this chapter. 
The potential risks to participants include:  
1) lack of comprehension and acknowledgement of informed consent, study 
purpose, and rights of participants;  
2) exposure to psychological or physical coercion by clinical staff and others;  
3) possible disclosure of confidential information;  
4) the possible mental discomfort associated with some of the sensitive issues 
raised during assessments and biological specimen collection and results; 
and  
5) social ramifications of participation in the study. 
 
7.1. 
Incident Reporting 
Incidents are defined as untoward events that occur during conduct of 
research projects and that affect research participants or staff or may affect 
study progress.  
It is the responsibility of study staff who becomes aware of incidents to report them 
promptly so that they can be evaluated, reported and responded to appropriately by 
the study management. Depending on what has occurred, a reported incident may 
also qualify as an adverse event (AE) or serious adverse event (SAE), social harm, 
protocol deviation, and/or require reporting to civil authorities.  
Examples of incidents that might occur during the study and should be reported 
include:  
• a participant becomes violent towards a staff member.  

 
 
• a participant reports to a fieldworker that she has suffered abuse from her 
husband because of her participation in the study or intervention.  
• a staff member learns of distrust or rumours spreading about the study in the 
community,  
• a staff member commits or becomes aware of a breach of confidentiality or a 
lapse in ethical conduct by staff,  
• protests / strikes / riots in the community that affect the work of fieldworkers.  
• occupational health hazards such as occupational TB,  
• a staff member becomes aware of child abuse in the home  
These and other incidents should be reported to the study management who will 
collate and triage all reports, and, depending on the category of incident, report to 
the study PIs, funders and regulatory bodies.   
7.1.1. Adverse Events (AE) 
Adverse Events (AEs) will be defined as: report of coercion to participate in the study; 
or significant hesitance, concern or emotional distress from answering research, such 
that the participant decides to stop their participation; and harm resulting from breach 
of confidentiality. Medical events for postpartum health, psychiatric issues including 
suicidal ideation, or substance abuse that do not require urgent medical attention, 
emergency care, and/or hospitalization will be also treated as AEs. We will monitor 
attrition rates for participants but drop out from the study will not be reported as an AE 
unless it is decided to be related to an untoward event from study participation. 
Clinically insignificant events are not considered AE’s. Examples of clinically 
insignificant events include mild viral illness (e.g., colds, flu, and runny nose), common 
headaches, minor scratches, and mild symptoms or problems associated with medical 
conditions not related to the postpartum periods. As per the definition of AEs, only 
significant worsening of baseline medical or psychiatric status or new problems will be 
reported as AEs. 
7.1.2. Serious Adverse Events (SAE) 
 
According to the South African Good Clinical Practice Guidelines (Department of 
Health; 2006), SAE is defined as “an event that is associated with death, admission to 

 
 
hospital, prolongation of a hospital stays, persistent or significant disability or 
incapacity, or is otherwise life-threatening in connection…” with the research study. 
For this study, an SAE includes neonatal deaths such as still born babies or 
miscarriages or any life-threatening events that requires urgent medical attention, 
emergency care, and/or hospitalization due to early labor. A SAE can also be regarded 
as any undesirable experience associated with the use of a medical product in a 
patient or any life-threatening occurrence which could lead to disability / permanent 
damage, death or other serious medical events (including outcomes that may 
jeopardize a participant or which may require medical or surgical intervention). 
Participants in this study are individuals at risk for postpartum depression and other 
psychosocial issues, and are thus, as a population, at risk for clinical worsening. 
Although we do not believe the study procedures or intervention places clients at 
increased risk for clinical worsening, we will review and report events of clinical 
worsening that leads to hospitalization. These events are not anticipated to occur on 
a regular basis. 
 
7.2. 
 Identification and Initial Reporting of Incidents 
The study depends upon staff to identify and report incidents promptly so that 
management can know about issues and respond appropriately. When study staff 
believe they have witnessed, experienced or learned of an event that fits the definition 
of an incident (AE or SAE), they should verbally report it immediately to the Project 
Coordinator. The staff member and the Project Coordinator will discuss the incident 
and if they agree it meets the definition of an incident, the Project Coordinator will 
provide guidance to the staff member, if needed, to complete, sign and submit the 
Incident Report Form.  
In the case that an incident poses a threat to a staff member, the staff member should 
remove themselves from the threat according to safety procedures. If participants 
experience any adverse reactions to the intervention part of the study, the staff 
member will contact the Project Coordinator and/or Site PI immediately for additional 
support. Based on advice from senior project staff, the field staff will make 
recommendations for appropriate referrals to medical, counselling and/or other health 
services.  

 
 
SAEs (e.g., death or hospitalization) will be reported within 24 - 48 hours of their 
occurrence by the Site PI, the PI, the SAMRC Research Ethics Committee, and our 
NIAAA project officer. SAEs will be reported regardless of whether they are considered 
to be study related. SAEs will be systematically assessed by staff at each participant 
contact as well as at each scheduled follow-up. At each follow-up, all research 
participants will be asked whether they had been hospitalized overnight in the past 30 
days. In the event that a participant either withdraws from the study or the investigator 
decides to discontinue a participant due to an SAE, the participant will be monitored 
by the investigator via ongoing status assessment until (1) a resolution is reached (the 
problem requiring hospitalization has resolved or stabilized with no further changes 
expected), (2) the SAE is determined to be clearly unrelated to the study intervention, 
or (3) the SAE results in death. The PI will review the study protocol with other senior 
research staff and/or the ethics committee and determine what further action to take 
based on the best interests of the participants and of the research. With input from the 
PI, the SAMRC Research Ethics Committee may recommend continuation of the 
study, modifications to the study, or termination of the study if unacceptable. 
Event 
Description 
Example 
Reporting 
Requirements/Actions 
Community/ 
Environmental 
Report 
Any incident in which 
events in the 
community/study 
environment directly or 
indirectly have a 
time/cost/quality effect on 
the study progress. These 
incidents are either 
observed, reported in the 
media or 
information obtained from 
community members 
Fires/Floods, natural 
disasters, taxi 
violence, service 
delivery strikes, 
development of RDP 
housing (temporary 
zone restructure 
resulting in 
community member 
migration), political 
activity, study team 
excluded from a 
community due to 
protest against the 
study 
Reporting to: 
Project Coordinator 
Senior Management: PI & Site 
PI  
Staff Safety 
Incident 
Incidents in which staff or 
any other person are 
threatened  
A participant or any 
other individual 
Reporting to: 
Project Coordinator 

 
 
becomes violent 
towards a staff 
Senior Management: PI & Site 
PI 
Participant Harms 
Social Harm 
1) Any untoward social 
occurrences that happen 
to a participant as a result 
of their participation in 
the study, or 
2) any untoward social 
occurrences that happen 
to a community, or groups 
or individuals within a 
community, as a result of 
implementation of the 
study intervention 
Participants provide 
confidential 
information and if this 
information is leaked 
it can have 
detrimental effects 
Reporting to: 
Project Coordinator 
Senior Management: PI & Site 
PI 
 
Protocol 
Deviation 
Protocol non-
adherence/violations (the 
research project’s 
processes not being 
followed) leading to 
individual incidents, 
trends or omissions that 
result in significant added 
risk to the participant, 
non-adherence to 
significant protocol 
requirements and 
significant non-adherence 
to GCP.  
-Enrollment of an 
ineligible patient. 
-Informed consent 
not obtained prior to 
performing protocol-
specified procedures. 
-Protocol-specified 
procedures not 
followed.    -Breach of 
participant 
confidentiality  
 
Reporting to: 
Project Coordinator 
Senior Management: PI & Site 
PI 
All Co-Investigators 
SAMRC Research Ethics 
Committee 
NIH Project Officer 
Critical Events 
Unanticipated 
Problems 
Any incident, experience or 
outcomes that is 
unexpected, has 
reasonable possibility of 
being related to a subject’s 
participation in the 
research and suggests that 
the research places 
participants or others at 
-Loss of a 
computer/tablet that 
contains participants’ 
private identifiable 
information. 
-Participant 
experiences physical 
violence (e.g., 
domestic) as a result 
Reporting to:  
Project Coordinator 
Senior Management: PI & Site 
PI 

 
 
greater risk of harm than 
previously known or 
recognized. 
of participating in a 
research study. 
-Unintentional 
disclosure of family 
member’s or partner’s 
health status due to 
participation in the 
research 
Suspected 
Research 
Misconduct 
Suspected fabrication, 
falsification, or plagiarism 
in proposing, performing, 
or reviewing research, or in 
reporting research results. 
-Study staff make up 
data to make it look 
like household visits 
were conducted that 
actually were not. 
-Staff falsify data on a 
questionnaire. 
-Study staff will report 
allegations of research 
misconduct to the PI and/or 
designee within 24 hours of 
becoming aware of the 
incident. 
-In instances when the study 
staff cannot notify the PI 
and/or designee for fear of 
punishment or another 
reason, the study staff will 
notify an appropriate person 
within their institution. 
-The PI and/or designee will 
notify the appropriate person 
within the institution (e.g., 
SAMRC REC), and the funding 
representative, of all 
applicable known facts about 
the allegation. 
Incidents 
Reportable 
to Civil 
Authorities 
Incidents reportable to civil 
authorities   include: 
Child abuse 
Child abuse is 
observed during a 
household 
visit or whilst in the 
field