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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

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

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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

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

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Introduction to the Monitoring in Clinical Trials, Pre-Study Site Selection Visit

• Post published: 31.07.2023

As per Good Clinical Practice (GCP) guideline “the purposes of trial monitoring are to verify that:

• a) The rights and well-being of human subjects are protected.
• b) The reported trial data are accurate, complete, and verifiable from source documents.
• c) The conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with the applicable regulatory requirement(s).”.

Clinical Trial monitoring is achieved via conducting the monitoring visits to Clinical Trial Sites (hereinafter referred to as “Sites”) either face-to-face or remotely.

The visits are performed by monitors (Clinical Research Associates, CRAs).

According to GCP guideline:

• “a) Monitors should be appointed by the sponsor.
• b) Monitors should be appropriately trained and should have the scientific and/or clinical knowledge needed to monitor the trial adequately. A monitor’s qualifications should be documented.
• c) Monitors should be thoroughly familiar with the investigational product(s), the protocol, written informed consent form and any other written information to be provided to subjects, the sponsor’s SOPs, GCP, and the applicable regulatory requirement(s).”.

The Sponsor of each Clinical Trial is responsible to develop a systematic, prioritized, risk-based approach to monitoring Clinical Trials. The Sponsor may choose on-site monitoring, a combination of on-site and centralized monitoring, or, where justified, centralized monitoring. The Sponsor should document the rationale for the chosen monitoring strategy (e.g., in the monitoring plan).

Centralized monitoring is a remote evaluation of accumulating data, performed in a timely manner, supported by appropriately qualified and trained persons (e.g., data managers, biostatisticians). Centralized monitoring processes provide additional monitoring capabilities that can complement and reduce the extent and/or frequency of on-site monitoring and help distinguish between reliable data and potentially unreliable data.

This article aims to briefly introduce the monitoring, describe the types of monitoring visits of Sites in Clinical Trials, and focus on a Pre-Study Site Selection Visit as a starting point in the monitoring process.

Depending on the timeframe (phase) in which each particular Clinical Trial Project is the following visits types are identified:

• Pre-Study Site Selection Visit (also known as Pre-Study Visit, Site Selection Visit, Site Qualification Visit)
• Site Initiation Visit
• Interim Monitoring Visit (also known as Routine Monitoring Visit)
• Close-out Visit.

Additionally, Co-Monitoring Visit(s) may be performed with the aim of either supporting the CRAs in their visit activities or assessing Site’s/CRAs’ adherence to Clinical Trial Protocol, GCP and other clinical research regulations. Co-Monitoring Visits are out of scope of this article.

Monitoring visits have typically one business day in duration, but depending on Clinical Trial complexity, amount of data to be reviewed and other factors their duration can be increased.

The main written documentation of each monitoring visit (irrespectively of its type) includes:

• Confirmation letter  – a letter/e-mail sent to Site well in advance of planned monitoring visit and which includes the details and activities to be done during the visit
• Visit report  – detailed description of all activities performed during the visit as well as all identified deficiencies, deviations, and action item(s)
• Follow-up letter  – a letter/e-mail sent to Site after the visit has been conducted and which includes the details of all activities performed during the visit as well as all identified deficiencies, deviations, and action item(s).

All confirmation, follow-up letters and Site Initiation Visit Report (per GCP requirements) are to be properly stored in Investigator Site File located at Sites.

Pre-Study Site Selection Visit (PSSV)

This is the starting point of interactions between Sponsor/CRO and Clinical Trial Site. It is performed after the Site Identification & Feasibility process has been completed.

The PSSV is performed to ensure that:

• A potential Principal Investigator (PI) is qualified and interested in conducting the clinical study
• The PI’s Site has adequate facilities, and resources to properly complete all required study activities
• Site has required pool of patients to complete enrollment.

Items to be reviewed/discussed may include, but are not limited to:

• Feasibility Questionnaire completed by Site
• Clinical Study Protocol/Synopsis and Clinical Study timelines
• Enrollment (recruitment) target, strategy, expectations, and availability of subject population
• Qualifications/ training, experience, interest and availability of the PI and Site Staff performing study related duties
• PI and Site Staff obligations, ICH-GCP / ISO 14155 guidelines (if applicable) and regulatory requirements
• Therapeutic area being investigated (including applicable standard of care)
• The PI’s/Site Staff’s regulatory inspection/audit experience, if any, and the outcome of the inspection/audit(s)
• IRB/IEC requirements, documentation, and approval timelines
• Site budget and execution of Clinical Trial Agreements
• Informed Consent Process and documentation requirements
• Source document and study record requirements, as well as Source Data definitions and Good Documentation Practice
• Monitoring visit process/schedule, PI and Site Staff availability, other competitive clinical trials with the same pathology run by Site
• The monitoring strategy including remote monitoring and remote Source Data Verification capacity and acceptance (if applicable)
• Electronic Data Capture (EDC) requirements, including vendor-specific experience, internet connectivity, and computer availability, if applicable
• Turn-around time for data entry and data query resolution
• Local country / Site-specific requirements for clinical study conduct (e.g., Site SOPs)
• Reporting and documenting safety events (e.g., Adverse Events, Serious Adverse Events, Adverse Events of Special Interest, SUSARs, pregnancy, study drug overdose etc.)
• Medical management of study subjects remotely, if appropriate
• Assessment of storage area and conditions for Investigational Medical Product (IMP) (includes Investigational Medical Device (IMD) and/or other study supplies/materials)
• IMP/IMD Accountability procedures (receipt, storage, dispensing, and record keeping)
• Laboratory sample handling procedures, including supplies, collection, and shipment.

During PSSV CRA ensures the adequacy of facilities where study subjects will be seen by visiting (touring) them (e.g., exam rooms for subject evaluation and treatment, laboratory and any special testing area, pharmacy (if applicable), any satellite sites (if applicable), working area for Site staff, data entry area etc.) CRA also ensures the adequacy of available equipment to be used in clinical study (including validity check for calibration/maintenance documentation).

As part of PSSV CRA requests/collects any required Site documentation which may include, but is not limited to:

• Confidentiality (Non-Disclosure) Agreement, if applicable
• Medical licenses (Institution and Site staff) and dated/signed Curriculum Vitae (CVs)
• Current GCP and ISO 14155 (if applicable) training certificates or certificates of relevant training(s) as listed on the corresponding CVs
• IRB/IEC membership list (roster), SOPs (if applicable) and statement of compliance
• Electronic Health Records related documentation, if used
• Completed dated/signed Project-specific forms and questionnaires required to qualify the Site, as applicable
• Local laboratory reference ranges, accreditation certificates and CV of Head of local laboratory if it will be used
• Dated/signed attendees log, Clinical Study Protocol, and Investigator Brochure acceptance pages.

The above documents may be collected as originals or copies, depending on Sponsor’s/country specific requirements.

On the basis of conducted PSSV and the review of all applicable documentation the Sponsor either approves Site’s participation in the given Clinical Trial or declines it.

If Site is approved CRA sends an appropriate Site Selection Letter and in case of disapproval – the appropriate Site Non-Selection Letter.

The above letters will thank PI and Site Staff for completion of Selection activities and will state the further actions to be completed (if Site is approved) or will explain the reason(s) for non-selection decision.

Carpathian Research Group capabilities

CRG as a CRO has extensive experience in conducting Pre-Study Site Selection Visits and choosing the most suitable Sites for successful Clinical Trial execution.

Information on all other Clinical Trial services that we provide could be found at  www.crg.global

You can contact us at  [email protected]

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Third party vendor management, execution of clinical trial agreements, the use of study forms at clinical trial sites.

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Clinical site monitoring visit letters: templates guide.

Sponsors or Contract Research Organizations (CROs) conduct several types of site visits at various stages of a clinical trial to ensure the quality and integrity of the data collected, compliance with protocols and regulatory requirements, and safety of the trial participants. These visits are an essential part of clinical trial management and oversight.

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Frequently Asked Questions About NCCIH Initiation Visits

When is an nccih initiation visit scheduled.

An NCCIH initiation visit occurs once the final protocol, CRFs, ICF, and DSMP are approved by NCCIH and the local IRB, and before any participants are enrolled in the study.

Who schedules the initiation visit?

With NCCIH approval, a monitor (sometimes referred to as a clinical research associate or CRA) will contact the PI or study coordinator by phone or email to begin scheduling a visit. The monitor will inquire about availability and scheduling preferences, providing as much notice as possible.

Once a mutually agreeable date is determined, the monitor will email a confirmation letter to the PI confirming the date and outlining the visit objectives. NCCIH staff will receive copies of this correspondence. The confirmation letter will be emailed to the PI at least 21 calendar days in advance of the visit.

How long does the initiation visit last?

The length of an initiation visit may vary according to the complexity of each study, but a typical initiation visit lasts about 7 hours. Not all parts of the visit require attendance by all staff.

What arrangements need to be made for the initiation visit?

The monitor will ask the site staff to reserve an appropriate meeting space for the visit. This request may also include equipment, such as a projector, screen, and/or conference phone line.

The monitor will ask in advance for campus directions and any visitor requirements specific to the site, such as visitor sign-in, parking tag, or a visitor badge.

Which study staff will attend the initiation visit and when?

All study staff responsible for the implementation of the study will attend the initiation visit. This typically includes the PI, co-investigator(s), study coordinator, research nurses, and/or other study staff who will interact with participants, as well as data management staff. If the study randomization scheme is of particular interest, the study statistician may be asked to attend while that topic is discussed. If a study agent is involved, the pharmacist may be asked to attend. Questions about staff attendance for individual studies can be discussed with the monitor as part of visit planning.

What study documents will the monitor review during the initiation visit?

The monitor will review the following NCCIH- and IRB- approved documents, as applicable to the study:

• Most recent protocol version

In addition to reviewing the documents listed above, the monitor will review the correspondence from NCCIH indicating approval of the protocol, as well as any correspondence between the PI and the IRB.

• Please refer to the Regulatory Binder Checklist [1MB Word file] and Summary Sheet [1MB Word file] for a complete list of regulatory documents that will be reviewed during the visit.

What topics will be discussed during the initiation visit?

The monitor will provide the site with a draft initiation visit agenda in advance of the visit, and will work with the PI, study coordinator, or other designee to finalize the agenda prior to the visit. The initiation visit agenda will include the following items, with modifications to reflect the specifics of each protocol and study team:

• Detailed discussion about the study procedures and NCCIH expectations for study staff
• Review of the protocol to ensure each member of the study team is familiar with the details of the study plan
• Verification that each member of the study team is clear about his/her role and responsibilities
• Verification that all documents necessary to begin study implementation are complete, such as required regulatory documents, standard procedures, quality control (QC) plan, CRFs, and checklists for source documentation if used
• Verification that the study database is ready for implementation
• Verification that the necessary study supplies are ready for use
• Verification per brief staff-guided tour that the facilities are adequate for study implementation

It is likely that the PI and other key staff will be presenters during the initiation visit. For example, the PI may provide an overview of the study plan, or the study coordinator may review the CRFs that will be used for data capture. All key staff should be prepared to lead the protocol discussion according to the visit agenda.

NCCIH representatives may elect to participate in the initiation visit in person or by teleconference.

How and when will the monitor’s findings be communicated to the site and to NCCIH?

The monitor will provide a verbal summary of the discussions and findings at the conclusion of the site visit.

In addition, the monitor will prepare a written report using an NCCIH-approved template specific for an initiation visit. The written report will describe the topics discussed, items reviewed, monitoring findings, and any Action Items for the site. The monitor will distribute the final report, reviewed by NCCIH, to the PI and relevant site staff 2 to 3 weeks after the visit.

Will any followup be required after the initiation visit?

The monitor’s written report will outline any Action Items that require followup, and the Action Items will also be listed in an Action Item – Site Response Form. The site will have 30 days after receipt of the monitoring report to respond to the Action Items identified in the report. The response to the Action Items should be submitted in writing to the monitor.

How will I know when the study may open to enrollment?

The study may open to enrollment upon receipt of written approval from the NCCIH program officer. Before NCCIH approval is granted, the site must show that all Action Items from the initiation visit have been resolved or there is an adequate plan for resolution in place.

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NCCIH Clinical Research Toolbox

Home » Letters » Confirmation Letters » Site Visit Confirmation Letter – Sample Confirmation Letter for Site Visit

Site Visit Confirmation Letter – Sample Confirmation Letter for Site Visit

From, __________ (Your Name) __________ (Your Address) __________ (Sender’s Details)

Date: __/__/____ (Date)

To, __________ __________ __________ (Recipient Details)

Subject: Site visit confirmation

Dear Sir/ Madam,

This letter is in reference to the invitation letter I/we received from your side for visiting ________ (mention site name/ address) on _______ (date) for ___________ (purpose).

I assure you that I will be present at the requested time and date. Kindly consider this as a confirmation of acceptance of the site visit.

In case of a change of timing or date or any other query, kindly contact me at ________ (contact number).

Truly, __________ (Signature) __________ (Name) __________ (Contact Details)

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Letter of Verification for Student Status

Michael T. Reynolds Registrar City University 123 College Lane Boston, MA 02115

Date: March 5, 2024

Alexandra G. White Human Resources Manager Innovatech Solutions Inc. 456 Industry Drive San Francisco, CA 94107

Dear Ms. Alexandra G. White,

I am writing to you in my capacity as the Registrar at City University, Boston, MA, to verify the student status of Ms. Jessica C. Hartley. This letter serves to confirm that Ms. Hartley is currently enrolled as a full-time student in our Bachelor of Arts in Digital Media program.

Ms. Hartley commenced her studies in the fall of 2021 and is projected to complete her degree requirements by the end of the spring semester in 2025. She has consistently demonstrated academic excellence throughout her enrollment, as evidenced by her cumulative Grade Point Average (GPA) of 3.7 on a 4.0 scale.

Additionally, Ms. Hartley has actively participated in various extracurricular activities, including the Digital Media Students’ Association and the Annual Digital Innovation Showcase. Her engagement in these activities underscores her dedication to her field of study and her capacity for leadership and teamwork.

Ms. Hartley is in good standing with the university, having fulfilled all her academic and administrative obligations to date. Her dedication to her academic and extracurricular endeavors exemplifies the qualities of a committed and diligent student.

Should you require further details or clarification regarding Ms. Hartley’s student status, please do not hesitate to contact my office directly at (617) 555-0147 or via email at [email protected] . We are confident that Ms. Hartley will continue to exhibit the same level of excellence and professionalism in her future endeavors.

Thank you for your attention to this matter.

Michael T. Reynolds Registrar City University [email protected] (617) 555-0147

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