close out visit follow up letter

Close Out Visit Follow Up Letter

May 9, 2052

[Client's Name]

[Client's Company]

[Client's Address]

Dear [Client's Name],

I trust this letter finds you well. I would like to express my appreciation for the opportunity to conduct the recent close-out visit with your team. It was a valuable experience, and I wanted to follow up to ensure that all aspects of the visit were satisfactory and to address any outstanding matters.

During our visit, we had the opportunity to discuss the project's milestones, outcomes, and any remaining tasks or requirements. I hope that the information and insights shared during the close-out visit were helpful in providing a comprehensive overview of the project's status.

I would like to inquire if there are any additional questions or concerns that have arisen since our meeting. Your feedback is crucial to us, and we want to ensure that all expectations have been met and that the close-out process aligns with your project requirements.

If there are any outstanding items or if further clarification is needed on any aspect of the close-out process, please do not hesitate to reach out. Our goal is to ensure a seamless and satisfactory project conclusion for [Client's Company].

Once again, I appreciate the collaborative effort and open communication throughout the project. It has been a pleasure working with [Client's Company], and I look forward to any future opportunities for collaboration.

Thank you for your time, and I am at your disposal for any further discussions or clarifications.

[Your Name]

[Your Title/Position]

[Your Company Name]

[Your Contact Information]

Letter Templates @ Template.net

Site Close-Out Visit Follow Up Letter Template (Medical Device)

29,00  € (excl. GST/VAT)

This downloadable site close-out visit follow-up letter template is a standardised format for documenting the results of a clinical trial site visit’s conclusion.

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Description

Why it is useful, how to use it.

• If you are preparing a site close-out follow-up letter, use this template as a starting point.
• Use the template as a benchmark to review and improve your own template.

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Should want to learn more about using the template or clinical investigations in general, it is covered in our online course: Introduction to Clinical Investigation for Medical Devices and ISO 14155 .

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Welcome to global health trials' tools and templates library. please note that this page has been updated for 2015 following a quality check and review of the templates, and many new ones have been added. please click on the orange text to download each template., the templates below have been shared by other groups, and are free to use and adapt for your researchstudies. please ensure that you read and adapt them carefully for your own setting, and that you reference global health trials and the global health network when you use them. to share your own templates and sops, or comment on these, please email [email protected]. we look forward to hearing from you.

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This is Degena Bahrey Tadesse from Tigray, Ethiopia. I am new for this web I am assistant professor in Adult Health Nursing Could you share me the sample/templet research proposal for Global Research Nurses Pump-priming Grants 2023: Research Project Award

I have learned lot..Thanks..

i was wondering why there is no SOP on laboratory procedures ?

Hi, Can you provide me the SOP for electronic signatures in Clinical trial

Do you have an "SOP for Telephonic site selection visit". Kindly Share on my registered mail ID

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Hi These tolls are very useful! Thank you

Do you have a task and responsability matrix template for clinical trial managment ? Best

I am very much happy to find myself here as a clinician

Dear Getrude

We have a free 14-module course on research ethics on our training centre; you'll receive a certificate if you complete all the modules and quizzes. You can take it in your own time. Just visit 'Training centre' in the tabs above, then 'short courses'.

Kind regards The Editorial Team

need modules on free online gcp course on research ethics

Estimados: me parece excelente el aporte que han hecho dado que aporta. por un lado a mejorar la transparencia del trabajo como a facilitar el seguimiento y supervisión de los mismos. Muchas gracias por ello

We also have an up to date list of global health events available here: https://globalhealthtrials.tghn.org/community/training-events/

Dear Nazish

Thank you, I am glad you found the seminars and the training courses useful. We list many training events (all relevant to Global Health, and as many of them as possible are either free or subsidised) on the 'community' web pages above. Keep an eye on those for events and activities which you can get involved with. Also, if you post an 'introduction' on the introduction group stating where you are from and your research interests, we can keep you updated of relevant local events.

Thanks so much. These are very helpful seminars. Please let me know any other websites/links that provide free or inexpensive lectures on clinical Research. Appreciate your help.

Hi Nazish, and welcome to the Network. The items here are downloadable templates for you to use; it sounds like you may be seeking lectures and eLearning courses? If so - no problem! You can find free seminars with sound and slides here: https://globalhealthtrainingcentre.tghn.org/webinars/ , and you can find free, certified eLearning courses here: https://globalhealthtrials.tghn.org/elearning . Certificates are awarded for the eLearning courses for those scoring over 80% in the quiz at the end of each course. If you need anything else, do ask! Kind regards The Editorial Team

Hi, I am new to this website and also to the Clinical Research Industry for that matter I only am able to see the PDF of these courses, just wanted to know are these audio lectures and also happen to have audio clips that go with the pdf?

This site is impeccable and very useful for my job!!!!

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Monitoring Close-Out Visit (COV) Report Template

Once a trial is finished, monitors make sure that documents are properly archived and data logs are complete and locked. This template includes a step-by-step checklist for monitors and covers all the important aspects of a monitoring close-out visit (COV). It complements our series of monitoring templates covering all aspects of monitoring from the starting line to the finish line. These templates are freely accessible and are suitable for all sites doing clinical research.

Has your site wrapped-up all of its trial activities?

The up-to-date and user-friendly Monitoring Close-Out Visit (COV) Report Template can be used to report a close-out visit.

The template is a step-by-step checklist that guides monitors through all the important aspects of a close-out visit (COV) and includes an action list and practical drop-down menus. It is part of a series of monitoring templates that includes:

• Monitoring Site Initiation Visit (SIV) Report Template
• Monitoring Visit Report Template

Monitoring Plan Template

• Routine Monitoring Visit and Close-Out Visit (RMV-COV) Report Template

This template is suitable for any monitor engaged in clinical research in Switzerland and abroad. We particularly recommend using this template within the SCTO’s CTU Network for investigator-initiated, multicentre studies.

This template was developed by the SCTO’s Monitoring Platform and first published in February 2022 and last revised in March 2023 (V2).

Monitoring Close-Out Visit (COV) Template, cover page

Monitoring Close-Out Visit (COV) Template, page 1

This template is licensed under CC BY-NC 4.0. Its content can be shared and adapted as long as you follow the terms of the license. To view a copy of this license, visit  http://creativecommons.org/licenses/by-nc/4.0/ .

• Monitoring Close-Out Visit (COV) Report Template V2 (last revised in March 2023) (docx, 1.27 MB)

Our templates and tools are free. As a publicly funded organisation, we strive to inform the public about the impact of our work and to continually improve our services. We therefore kindly ask you to leave us your email address so we can contact you with a short one-time survey. You may download the document without providing your personal data.

Related tools and resources

Guidelines for risk-based monitoring.

These guidelines describe the risk­-based monitoring procedures for clinical trials and help determine the recommended risk category for a clinical trial.

Position paper: Monitoring in Non-Interventional Human Research Projects

This position paper discusses and provides recommendations regarding the implementation of monitoring strategies for non-interventional human research projects.

The up-to-date and user-friendly Monitoring Plan Template can be used to set up a monitoring plan.

Risk Assessment Form for clinical research projects

The user-friendly Risk Assessment Form can be used to make a step-by-step assessment of a clinical research project's potential risks; it is in line with current GCP requirements.

Safety Expert Finder

The interactive Safety Expert Finder helps you connect with experts who can support you in the safety management of your clinical research study.

Safety reporting forms for clinical research projects

This set of comprehensive safety reporting forms addresses all aspects of safety reporting for clinical research projects.

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Insights for those starting, managing, and growing independent healthcare practices

Get expert tips, guides, and valuable insights for your medical practice

November 20, 2023

Checklists and Guides

Patient Scheduling and Retention

From checkup to follow up: A guide to effective patient recall with free templates

Follow-up appointments are an important part of patient retention and quality care. Here’s why they matter — and 4 templates to use when you reach out to patients.

Most Popular

At a glance.

• A robust patient recall process, emphasizing timely follow-up appointments, boosts patient retention and practice revenue
• A personalized approach to follow-ups fosters stronger patient-provider relationships and improves operational efficiencies
• Use our free templates for letters, calls, forms, and email patient follow-up communications to get started

Whether you're a newer or established healthcare practice, one fundamental truth prevails: your vitality depends on nurturing a dedicated and engaged patient community. Unfortunately, this task is not easy in today's competitive healthcare landscape. With more choices available than ever, modern patients have higher expectations of their healthcare providers. According to a 2023 patient experience survey by Tebra, 73% of respondents would contemplate leaving a practice due to a poor experience with a healthcare provider. This underscores the significant repercussions faced by practices that fail to adapt to these evolving demands — and patient recall's meaning for your success.

While the current landscape poses unique challenges, practices can effectively address and manage many of these issues. By strategically implementing a patient recall process, healthcare providers can mitigate patient attrition and enhance retention rates. To emphasize its significance, a 5% increase in patient retention can lead to a 25-100% rise in lifetime healthcare costs for an individual patient. When you realize how dramatically patient retention can affect your financial success, the importance of providing continuous patient care becomes clear.

In this article, we clarify the patient recall meaning and present a comprehensive patient recall guide to assist you in elevating patient retention rates. We'll delve into the reasons for follow-up appointments, how follow-ups enhance patient care, and 4 follow-up templates that you can start using in your practice immediately.

A guide to the patient recall process

While it is preferable to schedule a patient's next appointment before they leave their current one, many patients hesitate to book appointments months in advance. This hesitation stems from the uncertainty of their future schedules. Instead of risking potential rescheduling, these patients prefer to book follow-ups closer to the time of their appointment.

To adapt to this evolving patient behavior and minimize the risk of missed follow-ups, practices must establish robust patient retention practices with the patient recall meaning as the foundational element. This strategic approach ensures a proactive system that accommodates patients' scheduling preferences while guaranteeing they receive necessary follow-up care.

What is patient recall? 

Patient recall, meaning the process of reminding patients to schedule routine checkups or follow-up visits, is crucial for healthcare practices. Sending postcards and letters as reminders for well-child appointments resulted in significantly higher attendance rates for both the letter (75.0%) and postcard (73.7%) groups compared to the control group, which received no reminders (67.5%). Importantly, there was no statistically significant difference in show rates between the letter and postcard groups, emphasizing the effectiveness of postcard reminders in improving follow-up attendance rates. Patient recall not only helps individuals stay on top of their care but also ensures a steady flow of patients — and revenue. 

“ Patient recall not only helps individuals stay on top of their care but also ensures a steady flow of patients — and revenue. ”

While each practice’s patient recall process will be different, a successful process typically includes the following components:

1. Identify suitable segments

First, identify key groups that are prime candidates for recall campaigns. This could include people with uteruses due for annual exams, individuals with chronic conditions that require annual monitoring, and those due for annual vaccinations like flu shots. A good electronic health record (EHR) can help you to identify suitable segments and an integrated practice growth automation platform will streamline the messaging process.

2. Select communication channels

Recall messaging campaigns, especially for crucial medical needs like vaccines or follow-up appointments, can be highly successful. However, given that 70% of consumers penalize brands for communicating in undesirable ways , the choice of the right communication channel is crucial. According to Tebra's annual Patient Perspectives report , the majority of patients (67.3%) prefer receiving text messages, both for appointment-related reminders and reminders to schedule follow-up appointments (47%). Patient portals also emerge as a close second choice, with 37% of patients favoring them for appointment scheduling. 

3. Schedule appointments

Once you select your patient recall segments and communication channel, it’s time to schedule the appointment. Sending patient recall campaigns through email, text, or medical practice management software such as Tebra allows you to include self-service scheduling links. This streamlines the scheduling process and empowers patients to take control of rescheduling. With 44% of Tebra survey respondents admitting to canceling appointments in the past 12 months, employing digital booking solutions can alleviate the administrative burden of managing appointments over the phone.

It's worth noting that even the most extensive patient recall segments may miss some candidates. For this reason, it's a best practice to regularly execute a generic recall campaign. This helps to minimize patient attrition and guarantee a consistent stream of patients.

Ideas for post-appointment patient checkups

Follow-up appointments are a vital aspect of the ongoing support and monitoring necessary to prevent care gaps and enhance outcomes for patients with chronic conditions. However, even all patients benefit from preventative care, which is why it’s crucial to consider the various reasons for post-appointment patient checkups.

• New patient checkups: When patients initially visit a practice for specific concerns rather than for a comprehensive physical exam , physicians may have only a partial understanding of their medical history. Scheduling new patient checkups not only nurtures the budding patient-physician relationship but also creates an opportunity to comprehensively address other medical needs.
• Monitoring patients' symptoms: Post-appointment checkups provide an opportunity to monitor a patient's condition or symptoms. This allows healthcare providers to adjust the treatment plan and prescribe alternative medications if necessary.
• Reinforcing action plans: Healthcare providers reinforce the patient's understanding of their medical condition and course of care. These follow-up visits directly impact patient outcomes and engagement in the healthcare journey.
• Confirming medicine regimens: Follow-up visits help to ensure patients adhere to their medications, allowing healthcare providers to confirm proper usage or explore affordable alternatives. This proactive approach helps minimize the risk of complications and contributes to overall patient well-being.
• Continuous care for chronic conditions: Continuity of care is vital for patients with chronic conditions. Follow-up appointments provide the ongoing preventive care and close monitoring required to help manage such conditions.
• Verifying referral followthrough: If you refer a patient to a specialist or for tests or treatments, follow-up appointments help to verify that the patient has acted on these referrals and receives the care they need.
• Sharing lab results: Many healthcare processes involve diagnostic tests and lab work. Follow-up appointments provide the opportunity to explain test results and establish a treatment plan if required.

Importance of patient follow-ups to increase returning visits

Regardless of the reason for a follow-up visit, these appointments form an integral part of the continuum of care . This integrated system of care guides patients from preventive care through medical incidents, rehabilitation, and maintenance, ensuring the monitoring of symptom monitoring and treatment compliance.

This integrative approach has a few benefits:

• More positive outcomes : By maintaining active engagement with patients, healthcare providers can deliver better care. This fosters more positive outcomes and improves retention rates for the practice. The MIPS (Merit-Based Incentive Payment System) and MACRA (Medicare Access and CHIP Reauthorization Act) provide additional incentives for healthcare providers, offering positive payment adjustments for delivering high-quality care and improved outcomes.
• Fewer hospital readmissions: Timely follow-ups can help to identify health concerns before they worsen, reducing the need for hospital readmissions .
• Stronger patient relationships: Consistent follow-ups build trust and strengthen the patient-provider relationship, resulting in more engaged and satisfied patients.
• Operational efficiencies: Software patient follow-up systems streamline the care process, optimizing resource allocation and appointment availability. This is a significant factor that influences whether a patient chooses to remain with your practice.

By recognizing the multifaceted benefits of post-appointment patient checkups, you can provide higher-quality care and enhance the patient experience.

Further Reading

Patient follow-up template for letters, calls, forms, and email.

Whether through personalized letters, informative calls, forms, or efficient emails, the follow-up process typically requires preparation. These 4 ready-to-use templates can help you start reaching out to your patients today. 

Patient follow-up template: Mailed letters

Dear [Patient Name],

We hope this letter finds you in good health. At [Practice Name], we take the well-being of our patients to heart, and we noticed that it's time for your scheduled follow-up appointment.

Our dedicated healthcare team is here to assist you during your visit, whether you have questions, specific health goals, or any changes in your condition to discuss. Your health and well-being are our top priorities, and we’re here to support you along the way.

Please feel free to contact our office at [practice contact information] if you have any questions, need to reschedule your appointment, or require further assistance. We look forward to seeing you at your upcoming appointment.

Thank you for entrusting us with your healthcare needs.

[Your Name]

[Your Title]

[Practice Name and contact information]

Patient follow-up template: Phone calls

Hello, this is [Your Name] from [Practice Name]. I hope you're doing well after your recent visit.

As part of our commitment to your care, we encourage you to schedule a follow-up visit. I’d be happy to book your follow-up appointment today. Is there a time and date [enter timeframe] that works best for you? 

Thank you for entrusting [Practice Name] with your healthcare needs. We appreciate the trust you've placed in us, and we're fully committed to supporting your journey towards better health.

If you have any inquiries or wish to discuss anything further, please don't hesitate to reach out to us at [practice contact information].

Patient follow-up template: In-office form

[Practice Name] patient follow-up form

• Patient's full name: ______________________________________
• Date of birth: ______________________________________
• Contact number: ______________________________________
• Email address: ______________________________________

Follow-up details:

• Reason for follow up: ______________________________________
• Date of last appointment: ______________________________________
• Preferred date and time for follow up: ____________________________________

Patient's health and feedback:

• How are you feeling since your last visit?: __________________________________
• Have you experienced any new symptoms or changes in your health?: ______________________________________

Comments/concerns:

• Please share any concerns or questions: ______________________________________

[Practice Name] team's notes:

• Recommended action: ______________________________________
• Next steps: ______________________________________

Additional comments:

• Any additional comments or feedback: ______________________________________

By filling out this form, you help us provide you with the best care possible. We appreciate your time and cooperation.

Thank you for choosing [Practice Name] for your healthcare needs.

[practice contact information]

Patient follow-up template: Email

Subject: A quick check in from [Practice Name]

Your well-being is always our top priority, and we care about your health and experience with [Practice Name]. With that in mind, we'd like to schedule a follow-up appointment to monitor your progress and address any questions or concerns you might have. 

Please schedule an appointment that suits your schedule using the link below.

[scheduling link]

If you have any questions about your treatment plan, medications, or upcoming appointments, please reach out. We're here to assist you in any way we can.

Thank you for choosing [Practice Name] for your healthcare needs. We appreciate your trust and are committed to your well-being.

If you need anything or have questions, you can reach us at [practice contact information].

Best regards,

[Practice Name]

Better outcomes and enhanced patient satisfaction: Patient recall meaning for your practice

Despite the many challenges facing modern healthcare practices, the power to transform your patient experience and retention rates is in your hands. By putting the patient recall process into action and using the above patient follow-up templates, you can strengthen your practice, enhance patient satisfaction, and drive better health outcomes. Get started today and unlock a thriving practice and healthier patients.

You Might Also Be Interested In

How to get patients to keep coming back. Learn what influences patient choices and behaviors in the 2023 Patient Perspectives report .

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Kali Armstrong

Kali Armstrong is an experienced content writer with a background in sciences and storytelling. Her passion for writing led her to receive a BA in communication from the University of Calgary. She believes healthcare should be accessible to all, and aims to provide educational content that empowers individuals to understand their health. Prior to writing for The Intake, she contributed to Forbes, Thrive Global, and Inc.

Reviewed by

Baran Erdik, healthcare consultant and compliance expert

Baran Erdik, MHPA, has expertise in healthcare editing, administration, and policy. He currently works in healthcare compliance and consulting.

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How to Plan a Productive Site Monitoring Visit

by ClinEssentials Team | Feb 28, 2022 | Tools for Research Professionals , Clinical Research Associates , Clinical Research Coordinators , Tips for Research Professionals | 0 comments

Many Clinical Research Associates are unprepared for their clinical trial monitoring visits, which is an important part of their role. It is understandable – CRAs are busy and it can be hard to find time for planning where there are so many other tasks to complete right away.

Monitoring visits are when CRAs ensure their studies are staying in compliance and on track. Creating a plan for the allotted time is the best way to ensure a productive, efficient monitoring visit.

What Happens at a Clinical Trial Monitoring Visit

Monitoring visits are typically very full days – jam-packed with all of the action items the CRA and the site need and want to accomplish.

A CRA may visit a site for site initiation, an Interim Monitoring Visit (IMV) – also called a Routine Monitoring Visit (RMV), or a study close-out. IMVs are the most common and usually happen every 4-6 weeks. However, monitoring plans differ and are determined by the Sponsor or CRO before a trial begins.

3 objectives of a monitoring visit

While there are many things that a CRA wants to successfully complete at a monitoring visit, there are three main objectives for each visit:

• Discover any data errors and/or discrepancies
• Evaluate the site staff’s understanding of the protocol and procedures
• Determine compliance

Standard tasks, meetings and goals of a monitoring check-in visit

Tasks are based on the reason for the visit. Since an Interim Monitoring Visit is the most common, here are the general business items that a CRA will address at a monitoring check-in visit:

• Review the regulatory binder, study documentation, and CRF entries
• Audit screening, enrollment, visit, and follow up data
• Conduct Source Data Verification
• Perform a safety assessment
• Examine the investigational product and study supplies
• Evaluate study personnel and site facilities
• Meet with the Principal Investigator and site staff

The Association of Clinical Research Professionals (ACRP) created this extensive checklist of tasks for a monitoring visit .

CRAs are responsible for documenting everything they observe, notice, and discuss during a visit. Following the visit, this information is compiled into a clinical monitoring report. Here are 5 guidelines for writing a useful clinical monitoring report from MasterControl.

Consequences of being Unprepared for a Monitoring Visit

Being prepared for a monitoring visit is instrumental in the success of the visit. When both the Clinical Research Associate and the research site are prepared, monitoring visits run smoothly and efficiently. The patient volunteers, clinical research team, and CRO or Sponsor are all negatively affected when the CRA or the site staff has not taken the time to prepare for a monitoring visit.

Scheduling conflicts and unavailability of key team members can lead to important meetings that have to wait until the next visit.

The site may not have the necessary documents or the regulatory binder ready for the CRA to review, which is one of the primary activities for most monitoring visits.

When monitoring visits are not successful and all essential tasks and meetings do not occur, the trial can be delayed – and potentially over budget. Sponsors and CROs may lose trust in the site and the staff.

3 Steps for a Successful Monitoring Visit

With proper communication and a simple 3 step process, preparing for a monitoring visit does not have to be overly time-consuming. Plus, spending time in advance will be time saved through an efficient, organized visit!

• Plan the visit. Download this free checklist that will lead to a well-planned visit. It even includes a list of documents to have on your computer and in your work bag. (The checklist can be modified based on the protocol or directions from the research team.)
• Review the study protocol and have a thorough understanding of the entire document.
• Bring clinical trial monitoring tools! Use the Visit To Do List to stay focused and on task. Provide the site staff with a copy of the Action Item List – and use the other copy to write the Monitoring Visit Report and Follow-Up Letter.

For more tips, check out Dan Sfera’s YouTube video about how CRAs should prepare for a site monitoring visit .

Stop showing up unprepared for a monitoring visit! As a leader and essential member of the research team, the site staff will appreciate and respect you for your thoroughness and organization – and this will be evident in their work!

For more great ideas and monitoring tools that help Clinical Research Professionals become more efficient, visit www.clinessentials.com .

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Add Your Heading Text Here

What to include in the clinical trial study close-out checklist.

• March 19, 2021

Study close-out is an essential factor in a clinical trial study. This process ensures that all the clinical trial activities are rightly reconciled, recorded, and reported at the end of the study trial. Usually, a study trial is considered closed by clinical research companies when the study report is finalised and  the database is locked.

Why is study close-out important?

Study close-out is essential because of regulatory obligations, to keep track of the resources invested, to answer the research questions, and finally, for the contribution of generalizable knowledge and better medical care.

3 key areas in clinical trials which require immediate attention once the  research is completed:

• Document Management, Storage, and Retention: Once your research study is completed, you need to ensure that all the related study documents are maintained and stored in the research site for at least a year or as mentioned in the study contract Federal Regulations guidelines.

Post this period, and the study documents need to be archived properly in an off-site location. The documents should remain retrievable for another seven years or as mentioned in the study-specific agreement.

• Study Close-out Report: It is critical to submitting a study closeout report to the IRB while closing a trial study. The report is meant to inform the IRB about the study closeout activities, including study outcomes and any problems that might have arisen.

The report is to be written by the sponsor in case of a sponsored trial or an investigator if the investigator-initiated the study. The study report should include any record of serious adverse events or unexpected events if the study goal was achieved.

• Result Submission: The study must be first registered with ClinicalTrials.gov before publishing the results. The principal investigator has the sole responsibility to provide and maintain study-specific reports.

Listed below are the 6 different components of the study close-out checklist:

• Monitoring visits: Ensure there are site close-out visits in the sites participating in the clinical trial. Usually, there are two types of visits – Local QA and NIDA CCC. During a monitoring visit following items need to cover.

During a closeout visit, things required to be covered includes data integrity and query resolution, adherence to regulatory requirements, disposition of study material, etc. Know that close-out may not occur until the last participant the last visit has occurred.

• Study personnel: For any staff no longer participating in the study trial, an updated staff information form needs to be sent.
• Safety and regulatory: Ensure you have done all adverse event reporting. All protocol deviations must be reported too. Ensure you have completed all the regulatory files and have uploaded all the documents to the regulatory tracking system. If any action item is pending, ensure to close it before site-close out.
• Data cleaning: The success of a clinical trial depends on the quality of the data. Hence, ensure the data integrity is maintained throughout the clinical trial process. Generate data quality reports towards the end of the study trial and at close-out.
• Medication, supplies, equipment: Understand who has disposition authority and include it in the site closeout checklist. Start working towards maintaining a low supply inventory once you are approaching the study closeout. Know that while you can donate certain supplies like lab kits, needs, gel packs, shipping boxes, etc., you need to destroy medication wallet cards, waybills, prescription labels, etc.
• Storage and data retention: You have all the source documentation in one place. Ensure that for paper studies, all CRFs are completed, collected, and the legible copies are available in your study files. For electronic data, confirm that all electronic CRFs have been completed and submitted.

Wrapping Up:

Study close-out is an essential factor in concluding clinical testing successfully. This checklist will ensure you do not miss out on the vital points of study close-out.

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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

Conduct ↦ Monitoring ↦ Routine Monitoring Visit ↦ Follow-Up Letter

Was betrifft es warum ist das wichtig.

The monitor forwards a Follow-Up (FU) letter / e-mail to the Site-INV summarizing:

• The scope of the performed RMV , including a list of the performed action items
• Current and ongoing unresolved issues with suggestion for improvement and a timeline for resolution

Was muss ich befolgen?

If you are the study monitor, write a short FU / e-mail to the Site-INV and include:

• The status and progress of participant recruitment
• Monitoring activities performed (e.g. IC s reviewed, SD verification performed)
• If applicable, study protocol and/or GCP deviations
• Delivered supplies (e.g. lab kits, IMP/MD )
• Current and ongoing unresolved issues with relevant improvement and control measures and a timeline for resolution

The FU letter / e-mail should:

• Not contain any surprises or issues that were not previously discussed with the site
• Describe the status and progress of the study during the monitoring visit

The Site-INV files the FU letter / e-mail in the ISF .  The monitor retains a copy of the letter / e-mail

Wo kann ich Hilfe anfordern?

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

ICH GCP E6(R2) – see in particular guidelines

• 4.5 Protocol compliance
• 5.18 Monitoring activities
• 6.10 Access to source data / documents

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

• 9.2.4.7 Monitoring reports
• CTU – Clinical Trials Unit
• FU – Follow-Up Letter
• GCP – Good Clinical Practice
• IC – Informed Consent
• ICH GCP –International Council for Harmonisation Good Clinical Practice
• ISF – Investigator Site File
• IMP/MD – Investigational Medicinal Product/Medical Device
• ISO – International Organisation for Standardisation
• RMV – Routine Monitoring Visit
• SD – Source Data
• Site-INV – Site Investigator
• Ethical Dilemma
• Declaration of Helsinki
• Declaration of Taipei
• Ethics Committee
• Federal Office of Public Health
• International
• Human Research Act
• Transplantation Act
• Stem Cell Research Act
• Data Protection Act
• Medicinal Product Studies
• Other Clinical Studies
• Transplantation
• Standardized Transplant Products
• Gene Therapy, GMO, Pathogenic
• Ionising Radiation
• Medical Device Studies
• In Vitro Diagnostic Medical Device Studies
• Notified Bodies
• Projects with Data and Biological Material
• Further-use of Data and Biological Material
• Further-use and Informed Consent
• Deceased Persons Embryos and Foetuses
• Ethics Portal BASEC
• Swissmedic Portal
• Good Clinical Practice
• Document Identification
• Document Filing
• Requirement
• Qualifications
• Product Development
• Pre-Clinical Studies
• In Clinical Studies
• Investigator Brochure
• Pharmacovigilance
• Materiovigilance
• Clinical Data Management System
• EU Regulation
• Statistician Role
• Statistical Software
• The Population
• Intervention and Control Group
• Placebo and Comparator
• Study Outcome Endpoint
• Outcome Endpoint Description
• Sample Size Calculation
• Randomization
• Study Blinding
• Interim Analysis
• Predictor Variable
• Confounding Variable
• Risk-Based Approach
• Risk Identification
• Risk Evaluation and Prioritisation
• Risk Evaluation Matrix
• Risk Control Measures
• Sponsor-Investigator
• Site-Investigator
• Study Staff
• Biological Material
• Specimen / Sample
• Pre-Analytical Phase
• Data Coding / Anonymisation
• Incidental Findings
• In Research
• Human Research Ordinance
• Research with Biological Material
• Further Use of Biological Material
• Further Use and Informed Consent
• ISO Biobanking
• Quality Labels
• Feasibility
• Implementation
• Infrastructure
• Advancing Science
• Marketing Products
• Conflict of Interest
• Participant Protection
• Ethics Requirements
• Laws and Guidelines
• Institution Requirements
• Study Compliance
• Risk Categories
• Ethics Clarification
• Swissmedic Scientific Advice
• Swissmedic Pre-Submission
• Protocol and Synopsis
• Investigator's Brochure
• Risk-Benefit Ratio
• Participant Risk-Benefit
• Data Manager
• Statistician
• Computer System Validation
• Data Storage
• Back-Up and Recovery
• Research Question
• Feasibility Questionnaire
• Risk Assessment Form
• Study Requirement
• Site Qualification
• Quality of Biological Material
• Biobank Goverance
• Biobank Regulation
• Material Transfer Agreement
• Requirements
• Protocol Template
• Responsibilities
• Participant Risks and Benefits
• Participant Right
• Staff Qualification and Training
• Good Clinical Practice Training
• Infratructure and Maintenance
• Multicentre Studies
• Outsourced Services
• Participant Information Sheet
• Informed Consent Form
• General Consent
• Essential Documents
• Source Data
• Exemption from written Consent
• Fed. Off. Public Health
• Application Dossier
• Early Clarification Meeting
• Late Clarification Meeting
• Approval Medicinal Products
• Approval Medical Device
• Study Protocol
• Participant Information
• Insurance and Contract
• Study Documents
• Document Submission
• The Protocol
• Data Protection
• Specification
• Case Report Form
• Calculated Fields
• Data Coding and Anonymisation
• Data Confidentiality
• Quality Assurance
• Data Mgmt. Plan
• Data Monitoring
• Data Transfer Agreement
• The Hypothesis
• Data-Analysis-Set
• Primary and Secondary Analysis
• Analysis Method
• Missing Data
• Study Termination Criteria
• Justification and Description
• Process Verification and Training
• Verification
• Non-Compliance
• Risk-Based Monitoring
• On-Site Monitoring
• Central Data Monitoring
• Off-Site Monitoring
• Monitoring Plan
• Biobank Database
• Facilities and Materials
• Collection / Storage Containers
• Storage Equipment
• Equipment Maintenance
• Freezer Emergency Plan
• In Research Projects
• For Further Use
• Communication
• Sample Workflow
• Sample Collection
• Sample Transport
• Sample Reception
• Sample Processing
• Sample Storage
• Sample Distribution
• Sample Analysis
• Forms and Logs
• Non-Conformities
• Biobanking Staff
• Quality Control Indicators
• Method Validation
• Research Transparency
• Staff Delegation
• Definition and Handling
• Purpose and Requirement
• Site Initiation Visit
• Study Initiation
• Master and Site File
• Safety Management Plan
• Emergency Unblinding
• Access Rights
• Prerequisite
• Preparation
• Sample Traceability
• Packaging and Shipment
• Data Accuracy
• Pre-Screening
• Screening and Consent
• Documentation
• Patient Information
• Sponsor and Site-Investigator
• Drug and Device Accountability
• Ongoing Tasks
• Consent of Vulnerable Participants
• Inspection Conduct
• Audit Conduct
• Audit Certificate
• ReportingTimelines
• Study Documentation
• Patient File
• Medicinal Product
• Medical Device
• Other Clinical Trials
• Research Projects
• Adverse Event
• Serious Adverse Event
• (Serious) Adverse Drug Reaction
• Suspected Unexpected Serious Adverse Reaction
• Advanced Therapies
• Adverse Event / Adverse Device Effect
• Serious Adverse Event and Device Effect
• Device Deficiency
• Serious Events
• Responsibility
• Adding Stakeholders
• Data Import
• Interim Lock
• Data Translation
• Re-Evaluation
• Risk Documentation
• Note to File
• Corrective and Preventive Actions
• Follow-Up Letter
• Close-Out Visit
• Database Lock
• Notification of Closure
• Lessons Learned
• Study Registries
• Scientific Publications
• Reporting and Liability
• Registry Update
• Study Closure
• Doument Archiving
• Document Destruction
• Data Formatting
• Data Sharing
• Risk Reporting
• Study Records
• For Further-Use
• Destruction
• Analytical Results

Please note: the Easy-GCS tool is currently under construction.