CLINICAL STUDY REPORT

[Sponsor Name]

CLINICAL RESEARCH STUDY

[STUDY NAME]

STUDY NO.	VERSION NO.
STUDY DATES	REPORT DATE
INVESTIGATIONAL PRODUCT NAME
BRIEF STUDY DESCRIPTION
IND NO.	TRIAL PHASE
SPONSOR(S) NAME AND ADDRESS
FUNDING ORGANIZATION
PRINCIPAL INVESTIGATOR NAME AND CONTACT INFORMATION
MEDICAL MONITOR NAME AND CONTACT INFORMATION
COORDINATING CENTER (if applicable)
GCP STATEMENT	The study personnel performed this study (including the archiving of essential documents) in compliance with ICH Good Clinical Practice (GCP).

Signature Pages for Clinical Study Report

I have read this report and confirmed that, to the best of my knowledge, it accurately describes the conduct and results of the study.

PRINT NAME
AFFILIATION
ADDRESS
SIGNATURE	DATE
PRINT NAME
AFFILIATION
ADDRESS
SIGNATURE	DATE
PRINT NAME
AFFILIATION
ADDRESS
SIGNATURE	DATE
PRINT NAME
AFFILIATION
ADDRESS
SIGNATURE	DATE
PRINT NAME
AFFILIATION
ADDRESS
SIGNATURE	DATE

TABLE OF CONTENTS

Signature Pages for Clinical Study Report	2

Study Synopsis	3

Regulatory Approval	3

Ethical Conduct of Study	3

Patient Information and Informed Consent	3

Statement of Regulatory Approval	3

Study Personnel	3

1.	Study Team and Site(s)	3

2.	Study Objectives	3

Primary Objective	3

Secondary Objective(s)	3

3.	Background	3

4.	Study Design	3

5.	Subject Inclusion and Exclusion Criteria	3

6.	Study Enrollment and Disposition of Patients	3

Disposition of Patients	3

Study Intervention, Duration, and Route of Administration	3

7.	Study Procedures	3

Study Examination and Procedure Schedule	3

Schedule Explanations	3

8.	Safety Assessment	3

9.	Intervention Discontinuation	3

10.	Statistical and Analytical Considerations	3

11.	Data Collection	3

12.	Quality Assurance	3

Protocol Deviation Table	3

13.	Committees	3

14.	Results	3

Data Sets Analyzed	3

Demographics and Baseline Characteristics	3

15.	Publication	3

16.	References	3

17.	Supplements/Appendices	3

Study Synopsis

[Fill in a brief summary in each category]

TITLE
SPONSOR(S)
NAME OF FINISHED PRODUCT
NAME OF ACTIVE INGREDIENT(S)
FUNDING ORGANIZATION
SITE NAME	SITE NO.
STUDY PERIOD (FROM / TO)	DEVELOPMENT PHASE
STUDY DESIGN / METHODOLOGY
PRIMARY OBJECTIVE
SECONDARY OBJECTIVE(S)
NUMBER OF SUBJECTS	PLANNED	ANALYZED
SUBJECT SELECTION CRITERIA
PRODUCT, DOSE, AND ROUTE OF ADMINISTRATION
DURATION OF TREATMENT
DURATION OF SUBJECT PARTICIPATION AND STUDY
SCREENING
TREATMENT
FOLLOW-UP
STATISTICAL METHODS
SUMMARY CONCLUSIONS
EFFICACY RESULTS
SAFETY RESULTS
CONCLUSION
REPORT DATE

Regulatory Approval

The table below details the approval of the independent ethics committee or institutional review board (IRB).

RESEARCH FACILITY NAME AND NUMBER
INVESTIGATOR
ETHICS COMMITTEE / IRB
CHAIR
DATE FINAL PROTOCOL APPROVED
DATE AMENDMENT 1 APPROVED
DATE AMENDMENT 2 APPROVED
DATE AMENDMENT 3 APPROVED

Ethical Conduct of Study

Make a statement here certifying that the study was conducted in accordance with the current version of ethical guidelines.

Patient information and Informed Consent

Prior to screening for criteria, the study personnel obtained written informed consent forms from all participating patients.

In the space provided below, detail the procedure for obtaining informed consent and add a sample information sheet and consent form. (You can also link the sample information sheet and consent form to the appendix.)

Statement of Regulatory Approval

Insert the statement of regulatory compliance and agency here. Include a copy of the approval here or link to it in the index.

Study personnel

The following table shows the study personnel involved in this study.

TITLE	NAME	AFFILIATION
Principle Investigator(s)
Sponsor(s)
Project Manager(s)
Project Lead(s)
Research Associate(s)
Medical Advisor(s)
Laboratory Investigator(s)
Data Manager(s)

Study Team and Site(s)

List the study team and participating sites for this study.

Study Objectives

Primary Objective

List the primary study objective, including the hypothesis, in measurable language.

Secondary Objective(s)

Secondary objectives may include non-experimental objectives and may be related to a hypothesis.

Background

Describe the study problem and priority in short form. Include the medical and scientific rationale that justifies studying the problem. Include any data from other studies that is relevant to this intervention proposal. Include the name and description of the proposed intervention as well as the dosage, route of administration, period, and frequency of the intervention.

Study Design

Describe the study design and how it will answer the study question. This description should include the type of study, primary and secondary outcome(s), population, sample size, study location, period of enrollment and follow-up, intervention and route of administration, randomization (as necessary), and any other relevant protocol information.

Subject Inclusion and Exclusion Criteria

Provide statements describing how the participants met all the inclusion and exclusion criteria required for participation in this study. List the criteria. Clearly define the study population. For example, list the demographic criteria, required laboratory data, any prior therapies allowed or disallowed ability to understand and meet all study requirements, whether contraception is necessary, exclusion criteria, such as specific health status, use of excluded drugs, cancer status, and chemical dependency status. Detail the study’s withdrawal policy and link to the full documentation of any withdrawals that occurred during the study.

Study Enrollment and Disposition of Patients

Describe the methods and procedures for identifying and enrolling subjects, how those methods and procedures were documented, and any randomization procedures.

Disposition of Patients

The following table is an example of the Disposition of Patients

PATIENT DISPOSITION	NUMBER OF PATIENTS (N)
PATIENTS SCREENED
Screening Failures
PATIENTS ACCEPTED AND RANDOMIZED
Group A
Completed:
Received (Prime)
Received (Prime)
Received (Boost)
Received (Boost)
Attended (Visit)
Completed (Visit)
Withdrawn:
Lost to Follow up
Adverse Events
Death
Other
Group B
Completed:
Received (Prime)
Received (Prime)
Received (Boost)
Received (Boost)
Attended (Visit)
Completed (Visit)
Withdrawn:
Lost to Follow up
Adverse Events
Death
Other

Group A (N= )	Group B (N= )	Total (N= )
Enrolled
Received at least one dose
Received all (x) injections and attended (visit)
Completed (visit)
Withdrawn:
Lost to follow up
Adverse event
Death
Other

Study Intervention, Duration, and Route of Administration

This section should describe each intervention, each intervention’s duration, and how each intervention was administered. List any adverse effects that occurred as well as any instances of dose escalation, if applicable. Discuss how the intervention was acquired, stored, and disposed of. Also, discuss the documentation for intervention accountability. In addition, detail other medications that were restricted, allowed, and required. Finally, discuss the extent to which patients complied with the instructions regarding these medications.

Study Procedures

Detail the following in the study procedures:

Treatments Administered

Description of Investigational Products

Assignment of Patients to Treatment Groups

Dose Selection in the Study

Dose Timing and Selection for Patients

Prior and Concomitant Therapies

Compliance to Treatment

Study Examination and Procedure Schedule

Insert a chart for the management of assessments performed and the periods of evaluation. Adjust and fill in the chart as needed. Examples of required evaluations and suggested periods are started for you.

ASSESSMENT	SCREENING APPOINTMENT	VISIT 1	VISIT 2	VISIT 3	VISIT 4	FINAL VISIT
Informed Consent	X
Demographics	X
Medical History	X
General Physical Exam	X
Treatment Administration Form	X
Adverse Events Form	X	X	X	X	X

Schedule Explanations

You can use this section to explain the required assessments, the nature of each period, and any special considerations or necessary instructions. These details should match the information in the column headers of the chart above. These details should include information on the screening or baseline assessments, randomization, blinding, follow-up visits, and final assessments.

Safety Assessment

This section should list any adverse events and how these were managed. Also, list and/or discuss the following efficacy and safety measurements:

Performance Status

Disease Status (CT Scans)

ECGs

Clinical Assessment of Injection Site

Clinical Exam

Vital Signs

Safety

Lab Testing

Hematology

Serum Chemistry

Urinalysis

HBV, HCV, HIV, Pregnancy

Cellular Immunology

Intervention Discontinuation

In this section, list all the criteria for intervention discontinuation and how these criteria were met. Include the reasons for discontinuation, any modifications to the schedule that occurred, the duration of follow-up, any temporary discontinuations, and any evaluations if participants were temporarily or permanently discontinued from the study.

Statistical and Analytical Considerations

This section should include the primary and secondary statistical hypotheses, why the study design was chosen, the primary and secondary outcome measures, and the validity and reliability of these measures. It should also include the sample size and randomization, the treatment assignment procedures, how the population was defined, any interim analyses, the primary and secondary outcome analyses, the statistical methods used to consider any necessary intervention effect between groups, and, if necessary, the expected positive group correlations among different study arms.

Data Collection

This section details the data collection: how the data was collected, the required forms, how these forms were kept confidential, and what source data was collected.

Quality Assurance

In this section, describe the training for the study staff, whether there was a control committee and their required practices, any quality control metrics, how protocol deviations were identified and documented, how protocol compliance will be assured, and the schedule for reviews. If there is a manual of procedures (MOP), it may be referenced here. Additionally, include any changes in the conduct of the study, changes to planned analyses, or protocol amendments (attached here or in the appendix).

Protocol Deviation Table

DEVIATION	SITE OCCURRENCES	SITE OCCURRENCES
Entry Criteria
Withdrawal Criteria
Dosing Regimen
Concomitant
Treatment or Medication
Other
Other

More information about deviations may be found here or attached in the appendix.

Committees

In this section, list any committees associated with the study along with their role in the study.

Results

Data Sets Analyzed

In the space provided below, discuss the data sets that were analyzed.

Demographics and Baseline Characteristics

Publication

Below, outline the requirements and procedures for publication.

References

Below, list any citations that were referenced in this protocol.

Supplements/Appendices

In this section, include any additional documentation or appendices.

DISCLAIMER Any articles, templates, or information provided by Smartsheet on the website are for reference only. While we strive to keep the information up to date and correct, we make no representations or warranties of any kind, express or implied, about the completeness, accuracy, reliability, suitability, or availability with respect to the website or the information, articles, templates, or related graphics contained on the website. Any reliance you place on such information is therefore strictly at your own risk. This template is provided as a sample only. This template is in no way meant as legal or compliance advice. Users of the template must determine what information is necessary and needed to accomplish their objectives.