CONFIDENTIAL
ACRIN ####
AMERICAN COLLEGE OF RADIOLOGY IMAGING NETWORK
ACRIN 66##
INSERT TITLE TO THE PROTOCOL
ACRIN PROSPECTIVE TRIAL TEMPLATE
[Include phase (phase I, phase II, etc.), design of the trial, if the trial is multi-center, the investigational agent, and the and target disease]
Study Chair
Insert the Name of the Study Chair
Insert Department Name/Affiliation
Insert University/Affiliation
Insert Address
Insert Phone Number
Insert Fax Number
Insert e-mail address
Other co-investigators as needed
Statistician
Insert the Name of the Study Chair
Insert Department Name/Affiliation
Insert University/Affiliation
Insert Address
Insert Phone Number
Insert Fax Number
Insert e-mail address
Original Date: Insert date of final and approved protocol
Version Date: Insert date of first amendment of the protocol (Any additional amendments will be inserted as necessary)
Activation Date: On activated protocols only
CONFIDENTIAL
This protocol was designed and developed by the American College of Radiology Imaging Network (ACRIN). It is intended to be used only in conjunction with institution-specific IRB approval for study entry. No other use or reproduction is authorized by ACRIN, nor does ACRIN assume any responsibility for unauthorized use of this protocol.Table of Contents
Schema
1.0 Abstract
2.0 Background and Significance
3.0 Specific Aims/Objectives
4.0 Study Overview
5.0 Participant Selection
6.0 Site Selection
7.0 Online Registration [and Randomization] System
8.0 Study Procedures
9.0 Data Collection and Management
10.0 Data Collection Forms
11.0 Image Submission
12.0 Adverse Events Reporting
13.0 Ethical Considerations
14.0 Conflict of Interest
15.0 Publication Policy
16.0 Institutional Audits
17.0 Statistical Considerations
References
Appendix I: Sample Informed Consent Form
Appendix II: Registration/Eligibility Checklist
Appendix III: Participating Institutions
Add other appendices as needed
AMERICAN COLLEGE OF RADIOLOGY IMAGING NETWORK
ACRIN XXXX: Insert Full TITLE of protocol
SCHEMA
Include a simple schema illustrating the procedures and timelines.
This section of the protocol should contain the following information:
SPECIFIC AIMS/OBJECTIVES
Ø Study Objectives (brief statement of primary endpoints)
METHODS/METHODOLOGY
Ø Stratification criteria (if applicable)
Ø Arm(s) descriptions (if applicable)
Ø Procedure or treatment description
Ø Diagram of procedure or treatment sequence (if applicable)
Eligibility (see Section 5.0 for details)
Ø [Eligibility should appear as bulleted items]
Ø Note the main clinical disease and the key inclusion criteria (the entire list of the inclusion criteria will appear later in the protocol).
Required Sample Size
Ø Total number of subjects projected for the entire study (all sites combined for multi-center protocol)
study design
Ø Very brief description of the main elements of the study design and the primary endpoint to be used in the trial.
ACRIN #### Date: mm/dd/yyyy
Current version date of the protocol>
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ACRIN ####
1.0 ABSTRACT
This protocol for human research study is conducted according to US and international standards of Good Clinical Practice (International Conference on Harmonization (ICH) Guidelines), applicable government regulations (e.g. Title 45, Part 46 Code of Federal Regulations) and the American College of Radiology Imaging Network (ACRIN) research policies and procedures.
[Stated aims should coincide with Section 3.0.]
This section should contain information about the target disease. It should include descriptions of and information about the investigational agent or modality. Also include the rationale for the protocol/trial development with information about non-clinical and clinical data available to date. It is also appropriate to discuss why the risks are reasonable in relation to the anticipated benefits and/or knowledge that might reasonably be expected from the study.
2.0 BACKGROUND AND SIGNIFICANCE
This section should contain the following information:
Ø History of the procedure/treatment
Ø References to pertinent studies, and the rationale for the proposed modalities
Ø Public health impact – start with prevalence of disease(s) and expected morbidity/mortality
This section should summarize all available non-clinical and clinical data (published or available unpublished data) that could have clinical significance and have relevance to the protocol under development.
3.0 SPECIFIC AIMS/OBJECTIVES
This section describes the overall objectives, including primary and any secondary objectives/endpoints (if applicable):
Ø Questions to be answered by the results of the study
Ø Study end points, which correlate with endpoints in statistical section
4.0 Study Overview
Describe the approximate total number or range of participants to be recruited for study within the approximate recruitment timeframe. Provide an estimation or number of how many sites are anticipated to participate in the trial and the expected number of participants to be recruited by each site.
Should be brief description of procedures/treatment and follow-up and refer to appropriate Sections and Appendices for details.
5.0 PARTICIPANT SELECTION
5.1 Inclusion Criteria
Create a numbered list (i.e. 5.1.1, 5.1.2, etc.) of criteria participants must meet to be eligible for study enrollment (e.g. age, gender, targeted disease) at the time of the registration visit. It should include “must be able to provide a written informed consent.”
5.2 Exclusion Criteria
Create a numbered list (i.e. 5.2.1, 5.2.2, etc.) of criteria that would exclude a participant from study enrollment at the time of the registration visit. If appropriate, should generally include that the subjects cannot have an active drug/alcohol dependence or abuse history. Also consider whether women or men must use clinically approved birth control while participating on this study, or whether women must have a negative pregnancy test.
5.3 Recruitment and Screening
Describe how potential participants will be identified and recruited for the study (e.g. investigator, co-investigators and/or site investigators, clinical practices, physician referrals, institutional database, advertisements [handouts, brochures, posters, letters to referring physicians etc.]). It must be noted that all advertisements and any information being disseminated to potential study participants MUST be reviewed and approved by the institution’s local IRB.
Describe any screening requirements necessary to meet any noted inclusion or exclusion criteria (detailed information can be included in the “Study Procedure” section of the protocol).
5.4 Inclusion of Women and Minorities
(Depending on the study, this section on inclusion of women may or may not be necessary)
Both men and women and members of all ethnic groups are eligible for this trial. In conformance with the National Institutes of Health (NIH) Revitalization Act of 1993 with regard to inclusion of women and minority in clinical research the projected gender and minority accruals are shown below:
Gender and Minority Accrual Estimates
Females / Males / Unknown / Total /
Hispanic or Latino
Not Hispanic or Latino
Unknown
Ethnic Category: Total of all subjects
Racial Category
American Indian or Alaskan Native
Asian
Black or African American
Native Hawaiian or other Pacific Islander
White
More than one race
Unknown
Racial Category: Total of all subjects
Describe how the proposed study will target and recruit the population of men and women and members of diverse ethnic communities. Note: This chart is required only for Phase II and Phase III studies.
6.0 Site Selection
6.1 Institution Requirements
Describe any study-specific investigator/site qualifications and equipment requirements. If these are detailed, they may be summarized here and listed more fully in an appendix or in Protocol Specific Application.
6.2 IRB Approval and Informed Consent
All institutions must have study-specific Institutional Review Board (IRB) approval for the protocol and informed consent form. (The informed consent form is included in this protocol as Appendix <#>.) The investigator and the investigator-designated research staff must follow OHRP-approved consent procedures (Title 45, Part 46 Code of Federal Regulations), as well as those set by the local IRB at the institution. A copy of the IRB approval letter and a copy of the IRB approved, institutional study-specific consent form must be on file at ACRIN Headquarters (fax: 215-574-0300, ATTN: Protocol Development and Regulatory Compliance Department) prior to registering the first participant.
7.0 Online Registration and Randomization (optional: study specific) System
7.1 Using the Online Registration System
Once the investigator-designated research staff (i.e. the Research Associate [RA]) has completed the eligibility checklist (Appendix #) and the participant has been found to be eligible, the participant may be consented. Upon obtaining a signed informed consent form, the information of the study participant will be registered by logging onto the ACRIN web site (www.acrin.org), which is available 24 hours a day, 7 days a week. Please refer to the ACRIN Procedure Manual, Section 7.1, Participant Registration for instructions.
7.2 Unsuccessful Registrations
7.2.1 ACRIN and protocol-specific requirements for Institution participation are maintained within the Administrative database. The protocol specific attributes are then interfaced with the web application for on-line verification of site participation acceptance. If the institution has not met all the regulatory requirements based on the required attributions within the database, a screen that includes a brief explanation of the failure to gain access to the registration screens is projected. If during the completion of the eligibility questions a participant is deemed ineligible based on a response, a message box appears to instruct the research staff to contact the Data Management Center.
7.2.2 In the unlikely event that the ACR web registration site is not accessible, participating sites may still register a participant by faxing the completed eligibility checklist to the DMC at the ACR (215-717-0936, ATTN: PARTICIPANT REGISTRATION). ACR staff will fax a response to the registering site with the confirmation of registration and participant case number and randomization (study specific -- optional) as soon as possible.
8.0 Study Procedures
Describe all the study procedures and diagnostic treatments required at each visit. A study table that describes the activities and procedures to be conducted at each visit is useful and helpful. Include this study table as an appendix that can be referred to in this section.
8.1 Registration Visit
List all study procedures and activities to be performed at the registration visit.
8.2 Visit 1
Indicate the timeframe for this visit (e.g. Visit 1 will occur six (6) months from the registration/baseline visit with +/- one (1) week [a window/timeframe]). List all “follow-up” study procedures and activities to be performed at this visit.
8.3 Visit 2…etc.
Indicate the timeframe for this visit (e.g. Visit 2 will occur after six (6) months from Visit 1 with +/- one (1) week [a window/ timeframe]). List all “follow-up” study procedures and activities to be performed at this visit.
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<Current version date of the protocol>
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8.4 Study Parameters
Study Procedure / Pre-Registration Visit / VISIT 1: / VISIT 2: / VISIT 3: / VISIT 4: / Etc. /Signed Informed Consent
ACRIN Web Registration
Medical History
Medical Record
<Insert Study Procedures
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9.0 Data Collection and Management
9.1 General
9.1.1 The ACRIN web address is www.acrin.org.
9.1.2 Data collection and management will be performed by the Biostatistics and Data Management Center (BDMC) of ACRIN under the direction of Dr. Constantine Gatsonis. The Biostatistics Center (BC) is located at Center for Statistical Sciences at Brown University in Providence, RI, and the Data Management Center (DMC) is located at the American College of Radiology’s Data Management Department in Philadelphia.
9.1.3 Participant enrollment and data collection occurs through a series of programmed screens accessed through the ACRIN web site to register/randomize participants, collect participant data, and maintain calendars of data submissions for each participant. By using the World Wide Web, ACRIN has made participant registration, data entry, and updated calendar information available to clinical sites 24 hours a day, seven days a week. Each successful case registration is confirmed through receipt of an e-mail containing a registration/randomization confirmation and a case specific calendar identifying timelines for data and image submission. If the confirmation e-mail is not received, the enrolling person should contact the Data Management Center before attempting a re-registration.
9.2 Clinical Data Submission
§ Upon successful participant registration, a confirmation e-mail containing the registration and case specific calendar is sent to the research staff enrolling the participant via the web. In addition, the investigator-designated research staff may download the participant specific data submission calendar, which lists all forms and designated reports required by protocol, along with the form due dates at the DMC. These calendars will be updated as the study proceeds to reflect data that have been received, reply deadlines for queries about unclear data, deadlines for follow-up reports of adverse events, or changes in the protocol that change the data being collected or the timeframe. Updated calendars for each participant can be obtained 24 hours a day from the ACRIN website. The research associate may use the calendar as a case management tool for data submission and follow-up scheduling.
9.2.2 The investigative site is required to submit data according to protocol as detailed on each participant’s calendar, as long as the case status is designated as open/alive or until the study is terminated. The case is closed when all data have been received, reviewed and no outstanding data query exists for the case.
9.2.3 To submit data via the ACRIN website, the appropriate investigator-designated research staff will log onto the ACRIN web site and supply the pre-assigned user name and password. Case report forms will be available on the web site through a series of links. Each web form is separated into modules; each module must be completed sequentially in order for the internal programming to be accurate. The user selects the link to the appropriate form and enters data directly into the web-based form. As information is entered into the web form application, various logic checks will be performed. These logic checks look for missing data, data that are out of range, and data that are in the wrong format (e.g. character data in a field requiring numeric responses). Such errors will be detected as soon as the user attempts to either submit the form or move to the next data element. They must be corrected before the form is transmitted to the DMC. The user will not be able to finalize form transmission to the DMC until all data entered pass these logic checks. Forms that are not completed in one sitting can still be submitted and completed at a later date. The form will remain available on the web until the “Complete Form Submission” button is depressed.