preparation for site initiation visit

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Clinical site initiation visit checklist and best practices.

Medha Datar

• March 3, 2023

The clinical site initiation visit is a critical component of the clinical trial start-up process. It involves the CRA visiting the study site to ensure that the site is prepared to conduct the study according to the protocol and Good Clinical Practice (GCP) guidelines. The purpose of the site initiation visit is to confirm that the site has the necessary resources, procedures, and training in place to conduct the study and collect accurate data.

Here are some best practices for conducting a successful site initiation visit:

• Schedule the site initiation visit as early as possible in the study start-up process to allow sufficient time for addressing any issues that may arise.
• Confirm that the site has all the necessary study documents, including the protocol, informed consent form, case report form, and monitoring plan.
• Verify that the site has obtained IRB/EC approval and that all regulatory documents are complete and accurate.
• Ensure that all site staff has completed the required training, including GCP training, and that their CVs are up to date.
• Review the study drug or device management plan and confirm that the site has procedures in place for managing adverse events and protocol deviations.
• Explain the monitoring process to the site staff and discuss the CRA’s role in monitoring the study.
• Confirm that the site has a plan for managing subject enrollment and explain the subject screening and recruitment process.
• Review the case report form with the site staff and explain how to complete it accurately and completely.
• Discuss the communication plan between the site staff and the sponsor/CRO, including how to report issues and the frequency and format of study updates.
• Verify that the site has procedures in place for data management and document retention.

Here is a sample clinical trial initiation visit checklist for a Clinical Research Associate (CRA):

By following these best practices and checklists, the CRA can help ensure that the study is conducted according to the protocol and GCP guidelines and that high-quality data is collected. The site initiation visit is an important opportunity to establish a good working relationship with the site staff and to identify any issues that may need to be addressed before the study begins.

Cloudbyz Unified Clinical Trial Management (CTMS) is a comprehensive, integrated solution to streamline clinical trial operations. Built on the Salesforce cloud platform, our CTMS provides real-time visibility and analytics across study planning, budgeting, start-up, study management, and close-out. Cloudbyz CTMS can help you achieve greater efficiency, compliance, and quality in your clinical operations with features like automated workflows, centralized data management, and seamless collaboration. Contact us today to learn how Cloudbyz CTMS can help your organization optimize its clinical trial management processes.

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Site initiation visit (siv): clinical trial basics, what is an siv in clinical research, siv definition: site initiation visit.

An SIV (clinical trial site initiation visit) is a preliminary inspection of the trial site by the sponsor before the enrollment and screening process begins at that site. It is generally conducted by a monitor or clinical research associate (CRA), who reviews all aspects of the trial with the site staff, including going through protocol documents and conducting any necessary staff training.[ 1 ],[ 2 ]

Also known as a study start-up visit, the sponsor can only request an SIV after the site has been selected and formal agreements such as the CTA have been signed.

What is the purpose of an SIV?

Clinical trial SIVs are necessary to ensure that all personnel of a given site who will be involved in the clinical trial, such as investigators and study staff, thoroughly understand the trial protocol and are trained appropriately so as to handle their role and responsibilities. Furthermore, the site initiation visit has the aim of ensuring the trial site is operationally ready, with working infrastructure, tools, and any study materials needed.[ 1 ]

Given the scope of the SIV, clinical trial sponsors should schedule this visit well before enrollment so that there is plenty of time to comprehensively inspect all relevant processes, and to conduct further training or rectify any issues, if necessary.

Can the SIV be conducted before IRB approval?

IRB approval is generally necessary before the SIV is carried out. Clinical trial sponsors should select sites that are compliant with all applicable regulatory requirements, and after the site receives IRB approval for the research, the sponsor can conduct the SIV.

SIV checklist for thorough site initiation visits

Given the importance of the SIV, clinical trial sponsors should make the most of this inspection visit by coming fully prepared with a detailed checklist of what is to be confirmed during the SIV.

Clinical trial sites might receive a copy of this checklist so they can ensure that all relevant staff are present for the visit. Specific tasks to include in the SIV checklist include the following:[ 1 ],[ 2 ],[ 3 ],[ 4 ]

• Discussing the clinical trial’s objectives with study staff
• Educating the research team on Good Clinical Practices
• Reviewing the operation schedule for the protocol
• Discussing the enrollment and screening process, including clarifying the inclusion and exclusion criteria
• Reviewing the informed consent documents and procedure
• Clarifying procedures for storing, dispensing, and managing the investigational product (IP)
• Checking inventory for all required medical supplies and equipment
• Ensuring secure access to all digital platforms, i.e., correct usernames and passwords
• Touring the clinical trial site to ensure facilities are in proper condition
• Reviewing and discussing all clinical trial documentation, such as forms, surveys, SOPs, etc.
• Reviewing the data management system and any other technological solutions forming part of the site’s or sponsor’s workflow
• Ensuring that site staff are up to date on training and understand how to maintain essential documentation
• Reviewing the site/trial budget financial protocols, including any processes related to compensating trial participants
• Verifying and testing reporting procedures possible adverse events
• Leaving room for an open discussion of any specific concerns that trial staff may have

This checklist provides basic guidelines only, and should be built upon and customized for each individual study according to risk areas and specific protocols.

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Study Initiation visit – check all procedures in place

The visit is usually conducted by the trial coordinator or often a monitor on behalf of the sponsor. Essentially their aim will be to work with the sites to ensure that the site’s planned operational procedures fits with the requirements of the protocol and will ensure accurate data as well as safe and ethical conduct of the trial.

The initiation visit is held once sites have had their regulatory and Ethics approval in place and after all the essential documents have been retrieved for the site and sponsor files. There are a number of items that may be discussed at this visit: - Study protocol (study objectives, purpose, endpoints) - Reporting AEs and SAEs - Investigational drugs (storage, dispensing, destruction, accountability) or any procedures necessary for other types of intervention - Inclusion/Exclusion criteria of protocol - Patient Enrolment (including withdrawal criteria) - Case record form completion and error correction - Protocol compliance and deviation issues - Quality management In some cases, the sponsor may decide to waive the initiation visit either in particular sites or overall across the study. For instance where the sites have been used for a similar study previously, for simpler studies where the study procedures are straight forward and easy to follow or where the sponsor has decided that the investigator meeting will also act as the initiation visit.

Where this occurs, it should be made clear and documented in the study files what training has occurred to replace the initiation visit.

Preparing for the Initiation Visit - A meeting room should be available - A site checklist is used by the monitor or trial coordinator to ensure that all items have been covered during the initiation visit. - The monitor should check that all regulatory documents have been retrieved prior to the meeting. It is possible to retrieve the last of the documents at the initiation visit provided the site has confirmed that they have these documents at site for collection. - All trial staff should also be available at the visit. This includes the principal and sub investigators, study coordinators; pharmacist etc. if they can’t be all available at the same time, the monitor could split the visits over several times in the day to meet with all members of the trial team.

During the Initiation Visit

A useful technique for planning an initiation visit is the ‘trial walk-through’. Here those in the meeting work through the whole study from (usually) the perspective on a participant. This helps see how the trial will run on the ground logistically and enable any potential glitches to be identified. For example working through the process for a vaccine trial might work as follows;

1. Community engagement in the study areas to explain the planned trial with community leaders and then the whole community 2. Mothers present at clinic and are approach as a group to explain the trial 3. One to one consent discussions with each mother with a study nurse 4. Consent taking by clinical officer 5. History of child taken and blood sample 6. Sample labelled and prepared for cold transportation to laboratory 7. Child vaccinated 8. Mother reminded of follow up visit and contact details of locally based field worker 9. Samples transported back to lab within 3 hours 10. Samples received and processed in trial lab 11. Any abnormal lab results reported by to investigators 12. Follow up visit one 13. Adverse event reported and child needing treatment 14. Child late to next follow up visit and needing finding in community 15. Next follow up visit completed 16. Child ends trial

Going through the whole trial journey from the participant’s perspective enables many of the potential outcomes to be thought about beforehand and therefore enables the staff team to be prepared.

Generally a trial initiation visit should cover the following;

- All aspects of the study should be discussed as mentioned above but also to include lab sample collections, method of randomisation (where necessary), advertising and any other matter that needs clarification. - Where the study medication is already on site, the monitor will check that it is stored correctly and plans for dispensing have been agreed by the PI and Pharmacist. - Ensure that all participants have completed the site personnel log. - Check that sites have sufficient study materials such as CRFs (where necessary) lab kits and any other study specific kits for sites to start recruiting. - Discuss the site arrangements for archiving the study documents at the end of the study. - Retrieve the site contact details and establish the frequency of monitoring visits. - Retrieve any last bit of documentation (where applicable).

Post Initiation Visit - The monitor will complete the initiation report and file a copy of the report in the site file. - Any actions from the meeting will also be addressed and a follow-up letter forwarded the site to clarify any questions that were raised at the meeting.

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Site Qualification Visits and Site Initiation Visits

Thank you to Patient Recruitment Centre: Leicester for providing this content Version 1 - March 2023

Download .pdf version of Checklist here

Site Qualificatio n Visit Checklist

The purpose of a SQV is to assess whether it is feasible for a site to run a study from the sponsor perspective. You will still need an internal feasibility assessment to discuss the study in much more detail, in particular recruitment strategies and targets. 

Consider making a video tour of your facilities since this reduces staff burden and provides an overview of site. It also showcases your research department and can be used during the EOI process. You can find examples of this here . 

Book a room and establish if in person or virtual.

Be prepared to give a tour of your facility including relevant departments e.g. pharmacy.

Ensure you have display screen equipment for SQV slides. If your organisation does not allow encrypted or external devices, request that the slides are sent in advance.

Invite appropriate people from support departments e.g. pharmacy or radiology,  or consider if they will have a separate meeting with the sponsor.

Make sure you can accommodate the number of attendees, internally and from the sponsor and/or the CRO and allow for additional guests. 

Preparation Needed

Ensure your department is clean and tidy and be aware of confidentiality with departmental documents.

Review material provided e.g. protocol synopsis, training slides and compile questions.

Check you have equipment required e.g. fridge, freezer, centrifuge, and space resource. If not, make a list of what is required.

Collate any information about previous sponsor audits or site inspection outcomes.

During the Meeting

Ask the following questions:

 What is the status of the study?

 What are the study timelines?

 What is the expected target?

 What is the recruitment period?

 Number of UK sites?

 Is the protocol finalised? Can amendments be suggested by PI and site staff?

 If the study is already open what have the challenges been?

 What is the screen failure rate?

Identify any equipment that the sponsor will need to provide or fund and who will order them. Ensure this is discussed and clear at an early stage. Do not wait until SIV when the contract will likely have been finalised.

Review recruitment strategy.

 Will they allow PIC sites?

 What support do you need from the sponsor e.g. what advertising materials are provided? Is there the opportunity to suggest alterations?

Ask when the sponsor will inform the site if they have been selected or not.

After the Meeting

Follow up with any actions.

Be prepared to provide documentation such as GCP certificates, CV’s, calibration certificates, FDF, and a contact list of staff.

If you are not selected as a site, remember to ask for feedback.

Site Initiation Visit Checklist

Th e sponsor run the SIV, however the lead site staff can utilise this opportunity to ask any remaining queries regarding the protocol and identify any outstanding requirements.

Ensure you have display screen equipment for SIV slides. If your organisation does not allow encrypted or external devices, request that the slides are sent in advance.

Invite all staff who will be working on the study. If they are not available they can review the slides after the event. Best practice would be to book SIV when all key site staff are available. The PI may only be needed for part of the meeting.

Invite appropriate people from support departments e.g. pharmacy or radiology and consider if they will have a separate meeting with the sponsor.

Make sure you can accommodate the number of attendees internally and from the sponsor/CRO. Be prepared for additional external staff to attend.

Some SIVs can last the full working day. Ensure you are clear on how long the meeting is meant to be and ensure you are aware of lunch arrangements i.e. is the sponsor providing or funding.

Prepare any questions you have about the study beforehand.

Review whether everything is in place for starting the study - IMP,  lab kits, system accesses, all documents including site files, equipment e.g. ECG, medical devices. This may not be the case for some studies with expedited set up.

Ensure you know the protocol.

Ensure someone is in attendance that knows the contract, in case any activities are discussed that are not included in the contract.

Complete the SIV attendance log or send a list of attendees to the CRA.

Circulate the delegation log  if not already completed.

Raise any queries about missing equipment, documents etc.

Review inclusion and exclusion criteria.

Source document review  - Agree what documents are source and what electronic systems the monitors will need access to.

Decide who will be reviewing the safety reports.

Record the SIV training on the finance tracker so it can be invoiced.

Put a plan in place for screening the first participant.

Review the participant recruitment pathway.

Consider a dummy run especially if numerous support departments are involved.

Request any amendments to the contract that are identified.

Make worksheets if not already prepared at this point.

Site Initiation Visits: Starting Your Trial On Track

by Siron Clinical | Mar 31, 2022

To get the best start with a clinical trial, we carry out a site initiation visit (SIV). In this post, we look at what that entails and how we ensure it sets the trial off in a positive direction.

When setting up a clinical trial, there are many steps to take, both on the approval side and the logistics side. At certain points in the process, the Clinical Research Associate (CRA) working on the trial is on the ground, visiting sites and talking to the people who will be running the study. One of these points is the site initiation visit (SIV).

The SIV happens once a site has been chosen for a clinical trial and received IRB approval, and when a Clinical Trial Agreement is in place. The aim is to make sure a site is ready to start enrolling participants. To do this, the CRA carries out checks, runs through the trial plan with everyone involved and provides training.

Why Does A Trial Need An SIV?

Typically, a clinical trial involves many people with different responsibilities and tasks. The process can be complex, and there might be several groups of participants involved. To make sure the trial runs smoothly and produces useful, meaningful results, everyone involved needs to understand and be prepared for their role in the process. This is what the SIV is designed to achieve. Held in-person at the site or virtually, the SIV usually involves everyone who will be working on the trial, including the principal investigator (PI), study coordinator, staff who will interact with participants, and those involved in managing data. The CRA has a checklist to ensure all the elements of the visit are covered. Let’s look at some of the main points.

Training Study Staff During the SIV, the CRA ensures all study staff are trained on the clinical trial protocol. For this to be effective, the CRA needs to know the protocol in detail – with in-depth knowledge of the protocol, the CRA is equipped to answer questions from the study team. CRAs often need to gain this in-depth knowledge quickly, so they need the ability to assimilate a large amount of information fast. The training will depend on the site and the type of trial. Some sites and study teams are well-versed in the process and will only need details specific to the new trial. Others might have less knowledge and experience of the clinical trial process and will therefore require broader training. By the end of the training, everyone involved will understand their role in the process.

Presenting The Protocol The CRA’s task is not only to present the protocol, but to engage the team. The doctors, nurses and pharmacists involved in the study are busy, and making them sit through hundreds of presentation slides may not give the trial the best start. Instead, the CRAs give the team the chance to ask questions, in an interactive session. They answer any questions the PI and other staff have about the study, and address any issues before the trial starts. The presentation might cover the design of the trial, the drug or treatment being tested, and any relevant background information about the therapeutic area, always keeping the audience in mind. Details like eligibility criteria for enrolment, how to store and administer the drug, and quality management points are also included.

The Trial Walk-Through In a meeting with everyone involved, the CRA will lead the group in a walk-through of the study, often from the perspective of a participant. By looking at the process from enrollment to trial end, the CRA can ensure the whole team understands what lies ahead in the trial. They can also identify any gaps in knowledge and spot potential problems before they arise.

Checking Documentation And Equipment The SIV includes some logistical and physical checks. The CRA checks that the drug is on-site, available and correctly stored. They ensure the team has the necessary equipment, such as lab kits or ECG machines, and that those who need access have it. The CRA checks the relevant documentation has been completed, such as regulatory documents, informed consent documents. Finally, they ensure the relevant team members have access to the systems and portals they will use during the trial.

Why Experience Matters

While every study is different, a CRA applies the same skills to make each SIV a success. With experience across a range of trials in different therapeutic areas, a CRA can take the most effective approach to their presentation of the protocol, answer questions about the trial with confidence in their knowledge, and cover all bases to get the trial started in a positive direction.

At Siron Clinical, our CRAs have at least 15 years’ experience in setting up and running clinical trials – including site initiation visits. Find out more about how we can support you .

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Monitoring Planning

Monitoring is the act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded and reported in accordance with the protocol, SOPs, GCP and applicable regulatory requirements.  The clinical research monitor is the person with direct access to, and oversight of the site research activities. They conduct monitoring visits in accordance with a monitoring plan and provide feedback and training to sites as necessary.    

Regular site monitor visits can be broken down into four types: pre-study visits, initiation visits, periodic monitoring visits, and close-out visits. Study sites may also be monitored or audited by the FDA, Clinical Research Organizations (CROs), IRBs and sponsors.

Before  the study begins the monitor may come out for some pre study visits, or those may be conducted remotely. A site initiation visit will be conducted, in person or remotely, to formally document that a site is ready to begin engaging in the conduct of the trial.

At the start of the study the monitor should be identified, the site should be qualified by the OCR Regulatory Services team. For industry sponsored trial, a monitor will be provided. For IITs it would be necessary to identify a monitor for the study.  

The monitor is typically part of the Site Initiation Visit (SiV), led by the Regulatory Sponsor for the study. The monitor will then conduct ongoing monitoring, according to the data safety monitoring plan, throughout the trial.  

Your Easy Guide to Clinical Studies

Provides some background knowledge and basic definitions

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Starts with ethics and regulatory approval

Ends after successful study initiation

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Starts with last study visit completed

Ends after study publication and archiving

Set-Up ↦ Monitoring ↦ Site Initation Visit ↦ Preparation

What is it why is it important.

The Site Initiation Visit ( SIV) should be well prepared because it provides an important opportunity to train staff on study tasks and responsibilities .

In most cases, the SIV is performed by the monitor(s) who presents the planned monitoring procedures; while the SP-INV  or a delegate presents the study protocol .

The SP-INV can appoint other personnel to perform the SIV. However, the SP-INV must ensure that those performing the SIV are well-qualified and properly trained to perform this task.

What do I need to do?

As a SP-INV ensure that the monitor performs his or her tasks according to the monitoring plan .

If you are the study monitor, prepare the site for an upcoming SIV:

• Arrange a date for the SIV visit with the site and invite relevant staff
• Prepare an agenda with topics to discuss, including what processes and tasks to train
• Complete pre-study TMF and ISF filing . The ISF is handed over to the site at the SIV
• Ensure that IMP/MD is available at the study site and ready to use
• Confirm access to the study database needed for staff training
• Decide on who will be responsible for any staff training
• Prepare relevant study logs , such as the delegation log and a SIV training log
• Prepare a SD location list. In a multicentre study prepare an applicable list for each participating site

Prepare an easy-to-follow and relevant study presentation:

• Include diagrams or flow-charts. A clever designed image can replace highly complicated written procedures (e.g. the study design, safety reporting , analytical processes)
• A physician / Site-INV  or delegate can present and explain more complicated medical issues
• Make sure that the infrastructure needed for your presentation and training sessions is available at the site (e.g. a beamer, flip chart, video transmission, magnet board, material needed illustrate points)

In order to guarantee effective communication and training, use a local or common language. If needed, organise an interpreter who can participate at the SIV.

Where can I get help?

Your local CTU ↧ can support you with experienced staff regarding this topic

Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch

Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch

Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch

Geneva, Clinical Research Center, CRC, crc.hug.ch

Lausanne, Clinical Research Center, CRC, www.chuv.ch

St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch

Zürich, Clinical Trials Center, CTC, www.usz.ch

External Links

• swissethics – Information on safety reporting
• swissmedic – Information on safety reporting

ICH GCP E6(R2) – see in particular guidelines

• 4.11 Safety reporting
• 5.18 Monitoring activities
• 8. Essential documents for the conduct of a clinical trial

ISO 14155 Medical Device – see in particular section (access liable to costs)

• 9.2.4.4 Initiation of the investigation site
• 10.8 Safety Reporting
• Annex E: Essential clinical investigation documents

ClinO – see in particular article

• Art. 37 – 43 Safety Reporting

HRO – see in particular article

• Art. 20 – 20 Safety notification
• ClinO – Clinical Trials Ordinance
• CTU – Clinical Trials Unit
• GCP – Good Clinical Practice
• ICH GCP – International Council for Harmonisation Good Clinical Practice
• IMD – Investigational Medical Device
• IMP – Investigational Medicinal Product
• ISF – Investigator Site File
• ISO – International Organisation for Standardisation
• SAE – Serious Adverse Event
• SD – Source Data
• SIV – Site Initiation Visit
• Site-INV – Site Investigator
• SP-INV – Sponsor-Investigator
• TMF – Trial Master File
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Harris and Walz heading to Georgia as campaign seeks to build on convention momentum

Vice President Kamala Harris and Minnesota Gov. Tim Walz will launch a bus tour of southern Georgia next week, the duo’s first time campaigning in the state together and, as of now, their first public event after the Democratic convention in Chicago.

The pair will be using the momentum from the party’s convention to drive them into the last couple months of the general election. In addition to the bus tour, Harris and Walz are expected to tape their first joint interview next week and attend multiple fundraisers, most likely to take place in New York, California, Florida and Georgia, according to two sources familiar with the planning.

Following the tour, Harris will headline a solo rally in Savannah, Georgia. The trip will mark Harris’ seventh visit to the state this year and her second since launching her presidential campaign last month.

“Campaigning in this part of the Peach State is critical as it represents a diverse coalition of voters, including rural, suburban, and urban Georgians — with a large population of Black voters and working class families,” the Harris-Walz campaign said in a press release announcing the bus tour.

Harris and Walz’s visit will come as the Republican ticket ramps up its campaigning in the state. Vice presidential nominee Sen. JD Vance of Ohio held a campaign event in Valdosta on Thursday, following a rally by former President Donald Trump in Atlanta earlier this month. Republicans, too, have sought to capitalize on polling that suggests the party could pick up a larger share of Black and Latino voters this election cycle.

The southern Georgia bus tour is expected to echo the campaign’s bus tour of western Pennsylvania earlier this month, which included stops at a local campaign field office, a firehouse and a high school football practice.

Harris and Walz initially planned to visit Savannah during the campaign’s battleground state tour earlier this month, but they had to postpone the event due to Tropical Storm Debby.

Though it’s unclear exactly where Harris and Walz will go, southern Georgia is home to some of the state’s largest Black populations, including Dougherty County, which has the second-highest proportion of Black residents in the state. The campaign has opened field offices in the predominantly Black cities of Albany and Valdosta.

“The south Georgia region is a priority for the campaign: We have nearly 50 full time staff across seven offices in the area, including Valdosta. We have hosted more than 500 events in the region since May 31,” Harris-Walz Georgia campaign spokesperson Adelaide Bullock said.

Ranada Robinson, research director for the New Georgia Project Fund, said appealing to Black voters in both rural and urban areas will be critical to Harris’ success in the state, as it was to Biden’s victory in 2020.

“Black voters are the key to winning Georgia. Of course Black Georgians can’t do it alone, but we are absolutely the reason 2020 turned out the way it did,” she said. “Black voters had historical turnout, and it has to happen again for there to be victory in Georgia.”

Earlier this month, Harris held the second rally of her presidential campaign in Atlanta, an event that featured Megan Thee Stallion; the campaign said it attracted more than 10,000 people.

It then launched a mobilization effort in the state and now touts more than 35,000 volunteers, 174 staffers and 24 coordinated campaign offices sprawled across Georgia. The campaign refers to its ground game there as “the largest in-state operation of any democratic presidential campaign cycle ever in Georgia.”

The Harris-Walz campaign said it has recruited nearly 400,000 news volunteers nationally since Harris launched her presidential bid last month. The campaign refers to its ground game there as “the largest in-state operation of any democratic presidential campaign cycle ever in Georgia.”

Harris campaign chair Jen O’Malley Dillon identified Georgia as one of the campaign’s top targets, noting shifting demographics that could aid the vice president in expanding support from 2020.

“The Vice President’s advantages with young voters, Black voters, and Latino voters will be important to our multiple pathways to 270 electoral votes,” Dillon wrote in a recent memo.

Harris and Walz are also expected to barnstorm battleground states around Labor Day, before Harris focuses more of her time on debate prep ahead of her September matchup with Trump.

A Trump adviser said the campaign expects Harris will get a “bump” coming off the convention but compared it to a “sugar high,” saying they didn’t believe it will change the overall state of the race.

CORRECTION: (Aug. 25, 2024 2:05 p.m. ET) A previous version of this article misstated the number of volunteers the Harris campaign has in Georgia. It has 400,000 nationally, not in the state of Georgia.

Nnamdi Egwuonwu is a 2024 NBC News campaign embed.

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Kamala Harris, Hoping to Build Momentum, Plans Battleground State Tour Next Week

After accepting the nomination, Ms. Harris was flying back to Washington on Friday for a weekend respite before returning to the campaign trail next week.

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By Reid J. Epstein and Katie Rogers

Reid J. Epstein and Katie Rogers cover the Kamala Harris presidential campaign. They reported from Chicago.

Vice President Kamala Harris’s campaign for president is entering a new phase, shifting from a 33-day sprint to the convention to something more familiar: Preparing for a debate and pivoting to getting out the vote.

On Friday afternoon, Ms. Harris plans to fly back from Chicago to Washington, where she will spend the weekend decompressing from the mind-spinning turn of events that led to her accepting the Democratic nomination for president on Thursday night.

She will begin preparing for what will be her first national interview — which she has said will take place by the end of August — and for the Sept. 10 debate with Donald J. Trump, according to campaign officials briefed on her plans who were not authorized to reveal them before they are formally announced.

The officials said Ms. Harris will return to the campaign trail next week with events in multiple battleground states, where she will aim to extend the enthusiasm generated at this week’s convention in Chicago.

Gov. Tim Walz of Minnesota, her running mate who was plucked from relative political obscurity 17 days ago, will return to his state before heading back on the campaign trail next week.

Presidential candidates typically come out of their conventions trying to build momentum with bus tours or rallies. Ms. Harris’s choice to delay the traditional barnstorming reflects the supercharged pace of the last few weeks and the changed nature of modern campaigns, where social media posts can be as important as speeches. It also is evidence of a shift from a sprint to more of a middle-distance effort that requires endurance and speed in equal measures.

“Campaigns often do barnstorm, but this has been such a compressed schedule for her and she has a debate in 17 days,” said David Axelrod, the veteran Democratic strategist who worked on Barack Obama’s campaigns. “A little downtime and maybe even prep would make sense. As we just saw they have a plethora of first-rate surrogates who can and should be deployed when she is not.”

While Mr. Obama in 2012 left his re-election convention in Charlotte, N.C., for a swing through battleground states including Iowa and Florida — where he was memorably lifted into the air by a pizza proprietor — campaigns today rely less on the local media coverage generated by stumping across the country.

Campaigns now seek to reach voters as much on social media apps as in person, a reality that was evident in how the Democratic National Convention gave status to influencers willing to cheer for Ms. Harris and spread the campaign’s message that was equal to or better than what it gave the traditional press corps at the United Center.

Ms. Harris’s self-imposed deadline for a national interview, next Saturday, presents the next hurdle for Ms. Harris. It will be a break from the rhythm of stadium rallies she has hosted since she named Mr. Walz her running mate.

Mr. Trump does not have a robust campaign schedule in the coming days either.

The Republican nominee sought to divert attention to himself during the Democratic National Convention, holding an event each day in a different battleground state. Mr. Trump plans on Friday to cap the week’s events in Las Vegas and in Arizona, where his campaign has teased a special guest that many expect to be Robert F. Kennedy Jr., who suspended his independent campaign for president on Friday and endorsed Mr. Trump.

Mr. Trump is then expected to spend the weekend at his golf club in Sterling, Va., according to two people familiar with his plans. But he does not have any public events scheduled until Monday, when he will address the National Guard Association of the United States in Detroit.

“President Trump will be working nonstop like he always does and doing an interview this weekend, which is one more interview than Kamala has done in 33 days,” said Karoline Leavitt, a spokeswoman for the Trump campaign.

Mr. Trump did not remain quiet after his convention. Two days after it ended in Milwaukee, he traveled to Michigan for his first joint rally with his newly crowned running mate, Senator JD Vance of Ohio.

Michael Gold contributed reporting.

Reid J. Epstein covers campaigns and elections from Washington. Before joining The Times in 2019, he worked at The Wall Street Journal, Politico, Newsday and The Milwaukee Journal Sentinel. More about Reid J. Epstein

Katie Rogers is a White House correspondent. For much of the past decade, she has focused on features about the presidency, the first family, and life in Washington, in addition to covering a range of domestic and foreign policy issues. She is the author of a book on first ladies. More about Katie Rogers