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ICTR DDRS: IND Annual Progress Report Guidance and Template for Drug Products Version 3.0
IND Annual Progress Report for Drug Products:
IND Annual Progress Report Guidance and Template Drug
Products
ICTR Navigators
October 5, 2012
Version 3.0
Page 1 of 23

ICTR DDRS: IND Annual Progress Report Guidance and Template for Drug Products Version 3.0
1.0 Table of Contents
Section
Page
1.0 Table of Contents 2
2.0 Abbreviations 2
3.0 FDA Websites 2
4.0 Introduction 3
5.0 Guidance and Instructions 3
5.1 Reporting Period 3
5.2 Due Date 3
5.3 Number of Copies to be submitted 3
5.4 Annual Report Binding 3
5.5 Template Guidance Comments 4
5.6 Annual Report Header and Footer 4
5.7 FDA, CDER Mailing Address 4
5.8 Website Address Hyperlinks 4
5.9 Questions and Additional Information Contact 4
6.0 Template Guidance Contents 5
2.0 Abbreviations
IND Investigational New Drug
CFR Code of Federal Regulations
FDA U.S. Food and Drug Administration
CDER Center for Drug Evaluation and Research
CBER Center for Biologics Evaluation and Research
CDRH Center for Devices and Radiological Health
GCP Good Clinical Practices
GLP Good Laboratory Practices
GMP Good Manufacturing Practices
BLA Biologic License Application
NDA New Drug Application
PMA Pre-Market Application
IDE Investigational Device Exemption
3.0 FDA Websites
Within the document there are a number of links to various FDA forms, regulations, and/or guidance
documents. The list below contains additional useful FDA websites.
FDA Forms Website:
http://www.fda.gov/aboutfda/reportsmanualsforms/forms/default.htm
FDA Title 21 Regulations Search Engine (e.g., IND regulations 21CRF312) website:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm
FDA Running Clinical Trials Website:
http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm
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ICTR DDRS: IND Annual Progress Report Guidance and Template for Drug Products Version 3.0
FDA – CDER Investigational New Drug (IND) Application website:
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/Approval
Applications/InvestigationalNewDrugINDApplication/default.htm
FDA – CDER Drug Guidance documents:
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
4.0 Introduction
The enclosed information is intended to provide an overview of the process for submitting an
Investigational New Drug (IND) annual report for an active IND application as per the requirements set
forth in 21CRF312.33. This document is designed to be used for an active IND application for a drug in
which is submitted to the FDA Center for Drug Evaluation Research (CDER).
The details of 21CRF312.33 can be found at the following website.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=312.33
5.0 Guidance and Instructions
5.1 Reporting Period
The reporting period for an annual progress report is 12 months in length. The period for the
first report will be from the date the IND went into effect to the day before the next anniversary
date. The date the IND went into effect is the date the FDA stated the first human clinical trial
may proceed (i.e., the date of the letter, email, and/or phone call the FDA stating that their
safety review was complete and that the clinical trial may be started). (Note, the letter the FDA
sends indicating the initial clinical trial may start is also referred to as the FDA letter of “no
objection” or “may proceed” letter.) The anniversary date of an IND is the month and day the
IND went into effect. For example, if the IND when into effect on June 12, 2009, then the
reporting period for the annual report will be from June 12, 2009 to June 11, 2010, and
anniversary date would be June 12 of each year the IND is active.
5.2 Due Date
IND annual reports must be submitted to the FDA Division/Office/Project Manager overseeing
the IND no later than 60 days post the IND’s anniversary date. For example, if permission to
begin the first human clinical study was June 12, 2009, then the anniversary date for each year
that the IND is active will be June 12. Using the same example, the latest date the annual
report should be received by the FDA is August 11.
5.3 Number of Copies to be submitted
One original copy and two photocopies are required.
5.4 Annual Report Binding
IND submissions that are received loose or which are inadequately bound may be returned to
the Sponsor-Investigator for proper binding and resubmission which can significantly delay the
FDA review process.
If the annual report can be securely held together with a standard office staple, then there is no
need to place the report in any type of binder. Normally, if the report is 15 pages or less,
stapling is sufficient. If the report is longer than 15 pages or it cannot be securely held together
with a staple, then it will need to be bound by another means. In this case, we suggest that the
FDA Project Manager be consulted for additional instructions. Otherwise, use the binding
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ICTR DDRS: IND Annual Progress Report Guidance and Template for Drug Products Version 3.0
instructions included in the “IND Guidance and Template for FDA-CDER Products” posted on
the DDRS website (http://ictr.johnshopkins.edu/DDRS). When labeling the binders, should you
use binders, indicate on the binder label that the submission is for an Annual Report. Each
section of the report should begin on new page and index tabs should be used to mark each
section of the submission packet.
5.5 Template Guidance Comments
The enclosed template guidance is a suggested format based on federal regulations, guidance
documents, and previous experience. Within the template are references to applicable FDA
regulations, web addresses to FDA guidance documents, comments/instructions, web
addresses to FDA forms, and suggested formatting and/or language. These instructions outline
what may need to be included or inserted into a particular section and may also address special
considerations. As this is a basic template and each IND is unique, best judgment should be
used concerning the information to be included in the submission. The sponsor-investigator
may use this format or adapt it as appropriate for the particular investigational product being
evaluated. A blank template with just the cover letter, title page, and suggested section
headings and subheadings is available for download at the DDRS website.
5.6 Annual Report Header and Footer
The following are the suggested format of the headers and footers to be used with the annual
report. Note that headers and footers are not included in the template and must be inserted
manually and may be modified as necessary.
Header:
[Left Hand Side]
Annual Progress Report
[INSERT Date of Report]
[Right Hand Side]
IND # [INSERT Number],
Series # [INSERT Series number]
Footer:
[Left Hand Side]
[Right Hand Side]
John Hopkins University Page 1 of [##]
[INSERT: Sponsor-Investigator Name]
Confidential and Proprietary
5.7 FDA, CDER Mailing Address
Central Document Room
Center for Drug Evaluation and Research
Food and Drug Administration
5901-B Ammendale Rd.
Beltsville, MD 20705-1266
5.8 Website Address Hyperlinks
All hyperlinks to websites included are operational as of the date of this document. Please
contact the ICTR Research Navigators via the contact information below if any non-functional
hyperlinks are identified so that they may be updated.
5.9 Questions and Additional Information Contact
For questions regarding any of the information presented or use of the attached template,
please contact the ICTR Research Navigators at ICTR_Navigators@jhmi.edu or via telephone
at 410-955-8120 or 410-614-5383.
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ICTR DDRS: IND Annual Progress Report Guidance and Template for Drug Products Version 3.0
6.0 Template Guidance Contents
Section
Page
6.1 Cover Letter 6
6.2 Cover Page 7
6.3 Page Holder for 1571 8
6.4 IND Annual Progress Report 9
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ICTR DDRS: IND Annual Progress Report Guidance and Template for Drug Products Version 3.0
6.1 Cover Letter
[INSERT: Sponsor or Sponsor-Investigator letterhead or address]
[INSERT: DATE]
[INSERT: FDA Project Manager and CDER Office/Division]
Central Document Room
Center for Drug Evaluation and Research
Food and Drug Administration
5901-B Ammendale Rd.
Beltsville, MD 20705-1266
RE: Annual Report for IND Number [INSERT: IND Number “######”], for [INSERT: PRODUCT NAME]
Dear [INSERT: FDA Project Manager Name],
Enclosed please find the annual report for IND Number [INSERT: IND Number “######”] covering the
reporting period from [INSERT: starting date] to [INSERT: end date]. Please do not hesitate to contact
me at [INSERT: Sponsor contact information], if there are any questions or concerns regarding this
submission.
Sincerely,
[INSERT: Sponsor-Investigator Name]
[INSERT: Title]
[INSERT: Affiliation]
Enclosure:
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ICTR DDRS: IND Annual Progress Report Guidance and Template for Drug Products Version 3.0
6.2 Cover Sheet
INVESTIGATIONAL NEW DRUG
ANNUAL PROGRESS REPORT
Date of Report:
Reporting Period:
[INSERT: Month Day, Year]
[INSERT: Date Reporting Period began to Date
Reporting Period ended]
IND Number: [INSERT: IND Number “###,###”]
Drug Name:
Sponsor-Investigator:
[INSERT: Drug Name]
[INSERT: Name]
[INSERT: Title]
[INSERT: Address]
[INSERT: Phone Number]
[INSERT: Fax Number]
[INSERT: Email Address]
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ICTR DDRS: IND Annual Progress Report Guidance and Template for Drug Products Version 3.0
6.3 Page Holder of 1571
[INSERT both pages of the signed and dated FDA Form 1571 here]
FDA Form 1571
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083533.pdf
1571 Instructions
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/Approval
Applications/InvestigationalNewDrugINDApplication/ucm071098.htm#form1571
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ICTR DDRS: IND Annual Progress Report Guidance and Template for Drug Products Version 3.0
6.4 IND Annual Progress Report
IND Annual Progress Report Table of Contents
Section
Page
A. Individual study summary information ##
A.1 Ongoing clinical trials ##
A.1.1 [INSERT TRIAL NAME] ##
A.1.2 [INSERT TRIAL NAME] ##
A.2 Clinical trials completed during reporting period ##
A.2.1 [INSERT TRIAL NAME] ##
A.3
Confirmation that clinical trial oversight and monitoring are conducted per the
plans submitted in this IND
##
B.
Summary Information - Information obtained from clinical and nonclinical
investigations during the reporting period:
##
B.1
Summary of most frequent and most serious adverse experiences by body
system:
##
B.2 Summary of all IND safety reports submitted during reporting period: ##
B.3 List of subjects who died during participation and cause of death: ##
B.4
List of subjects who dropped out during the course of the investigation in
association with any adverse experience, whether or not thought to be drug ##
related:
B.5
Summary of information obtained pertinent to understanding the drug's
actions (dose response, bioavailability, information from other controlled ##
trials, etc.):
B.6
List of preclinical studies (including animal studies) completed or in progress
during the reporting period and a summary of major preclinical findings:
##
B.7
Summary of any significant manufacturing or microbiological changes made
during the reporting period:
##
C.
Description of the general investigational plan for the upcoming reporting
period to replace the plan submitted with the last annual report submission:
##
D.
Description of any revisions to the Investigator's Brochure as well as a copy
of the newly revised Brochure (if applicable):
##
E.
Describe any significant Phase I protocol modifications made during the
reporting period which have not been previously submitted to the FDA in a ##
protocol amendment:
F.
Summarize any significant foreign marketing developments with the drug
during the reporting period.
##
G.
Log of any outstanding IND related business to which a reply, comment or
scheduled meeting with FDA is expected or requested:
##
H. Attachments: ##
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ICTR DDRS: IND Annual Progress Report Guidance and Template for Drug Products Version 3.0
A. Individual Study Summary Information:
A.1 Ongoing Clinical Trials
A.1.1
A.1.1.1
A.1.1.2
Trial Title and other identifying information
Title: [INSERT: Title of Protocol]
Protocol ID Number: [INSERT: Protocol ID Number or N/A if none]
IRB Number:[INSERT: IRB Number]
Purpose of the study:
[INSTRUCTIONS: Write a brief description of the purpose of the study.]
Study Objectives:
[INSTRUCTIONS: Describe the study objectives. If there are more than a primary and a
secondary objective, add additional lines.]
A.1.1.2.1
A.1.1.2.2
A.1.1.3
A.1.1.4
A.1.1.4.1
Primary:
Secondary:
Subject population(s) under study:
[INSTRUCTIONS: Describe the study population(s) (e.g., Healthy normal controls, healthy
smokers, schizophrenia, etc…) that will be enrolled in the study.]
Subject Enrollment Status:
[INSTRUCTIONS:
Provide the information for the tables below.]
If enrollment is closed, or on hold for any reason, include a statement here explaining
the situation.]
Enrollment Time Table
Date Study Open to Enrollment:
Date Enrollment Closed:
Expected End Date of Study:
Months /Years Open to Accrual:
IRB Annual Approval Dates:
[INSTRUCTIONS: Insert N/A if the study
remains opens, but if closed and there are
ongoing follow-up or data analysis activities,
provide the date.]
A.1.1.4.2
Table of Cumulative Enrollment Summary:
Total planned accrual: ##
Number consented to date: ##
Number enrolled to date: ##
Number completed to date: ##
Number that withdrew/withdrawn from study to date: ##
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ICTR DDRS: IND Annual Progress Report Guidance and Template for Drug Products Version 3.0
A.1.1.4.3
Table of Enrollment Summary for this reporting Period
Number consented in this reporting period: ##
Number enrolled in this reporting period: ##
Number that withdrew or who were withdrawn from study
##
in this reporting period:
Number completed study in this reporting period: ##
A.1.1.4.4
Table of Total Number of Enrolled Subjects by Age, Gender, and Race
[INSTRUCTIONS for the Table of Total Number of Enrolled Subjects by Age, Gender,
and Race:
Federal regulation (21CRF312.33 (a)(2))states that the annual report must provide
the total number of subjects entered into the study to date, tabulated by age, gender,
and race. Below are three examples of tables (the third example actually consists of
2 tables) that can be used to report this information and which may be modified as
needed.
SPECIAL NOTE regarding the racial categories listed in the tables below:
o The FDA issued a guidance for industry document in September 2005
entitled “Collection of Race and Ethnicity Data in Clinical Trials.” This
guidance document describes the FDA‟s current thinking on the collection of
race and ethnicity information and the categories listed below are based on
this document. The document provides:
• Definitions of the racial and ethnic categories.
• Guidance regarding methods of collecting both racial and ethnic data.
o Based on previous experienced, even though „Hispanic or Latino‟ is an ethnic
category, it is suggested that this category be listed with the races.
o Before making any changes to these categories, it is strongly suggested that
the PI consult with the FDA Project Manager or review the guidance
document at the hyperlink below:
o Guidance Website:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Gui
dances/ucm071596.pdf]
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ICTR DDRS: IND Annual Progress Report Guidance and Template for Drug Products Version 3.0
EXAMPLE #1
Table of Total Number of Subjects Enrolled by Age, Gender, and Race:
Age Groups 18-29 30-39 40-49 50-59 60-69 70 +
Age not
Reported
Gender F M F M F M F M F M F M F M
Race
White, Not of
Hispanic Origin
Black or African
American, Not of
Hispanic Origin
Hispanic or Latino
Asian
Native Hawaiian or
Other Pacific
Islander
American Indian or
Alaska Native
More Than One
Race
Race Not
Reported
Totals per
Race
Gender/Age
Group Column
Totals
Age Group Totals
Total Females
Total Males
Total Subjects
EXAMPLE #2
Table of Total Number of Subjects Enrolled by Age, Gender, and Race:
Age
Gender
Race
18-29 yrs.
30-39 yrs.
40-49 yrs.
50-59 yrs.
60-69 yrs.
Female
Male
White, Not of Hispanic Origin
Black or African American, Not of Hispanic Origin
Hispanic or Latino
Asian
Native Hawaiian or Other Pacific Islander
American Indian or Alaska Native
More Than One Race
Race Not Reported
Treatment Group Control Group Total
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ICTR DDRS: IND Annual Progress Report Guidance and Template for Drug Products Version 3.0
EXAMPLE #3
Male
Table of Total Number of Subjects Enrolled by Gender and Race:
White, Not
of
Hispanic
Origin
Black or
African
American,
Not of
Hispanic
Origin
Hispanic
or Latino
Asian
Native
Hawaiian or
Other
Pacific
Islander
American
Indian or
Alaska
Native
More
Than
One
Race
Race Not
Reported
Total
Female
Total
Table of Total Number of Subjects Enrolled by Gender and Age:
18 –29 yrs. 30-39 yrs. 40-49 yrs. 50-59 yrs. 60-69 yrs. 70 + yrs. Age not
Reported
Total
Male
Female
Total
A.1.1.5
A.1.1.5.1
A.1.1.6
Brief description of available study results:
[INSTRUCTIONS: Write a brief description of study data and/or progress]
Publications, Abstracts, Presentations:
[INSTRUCTIONS: Provide citations for any of the above in which data from this study
was used.]
Registration and Result Reporting at ClinicalTrials.gov:
[INSTRUCTIONS:
This section of the template is optional as it is not a required by any federal regulation or
FDA guidance document to be included in the IND annual progress report. However, it
is suggested that Sponsor‟s (Sponsor-Investigator‟s) include this section to track
compliance with the Title VIII of the Food and Drug Administration Amendments Act of
2007 (FDAAA) clinical trial registration and reporting requirements.
Web Resources:
o Definitions of the bolded terms in quotes below can be found at
http://prsinfo.clinicaltrials.gov/definitions.html#RespParty.
o Additional resources pertaining to trial registration and result reporting requirements
can be found at:
• Clinicaltrials.gov Protocol Registration System Information Site
http://prsinfo.clinicaltrials.gov/fdaaa.html.
• NIH Grantees Clinicaltrials.gov and FDAAA Policy Site
http://grants.nih.gov/ClinicalTrials_fdaaa/
• FDA Certification (FDA Form 3674) Guidance (Draft)
http://www.fda.gov/RegulatoryInformation/Guidances/ucm125335.htm
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ICTR DDRS: IND Annual Progress Report Guidance and Template for Drug Products Version 3.0
Per Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA), all
“Responsible Parties” must register and report results of certain "Applicable Clinical
Trials."
o “Applicable Clinical Trials” must be registered at ClinicalTrials.gov no later than 21
days after the first patient is enrolled.
o The “Applicable Clinical Trial” information must be updated no less than once
every 12 months, unless there has been no change in the clinical trial information
during the preceding 12-month period.
o The recruitment status of the trial must be updated no later than 30 days after the
status of the trial has changed (e.g. open to accrual, closed to accrual, terminated,
etc.).
o The “Primary Completion Date” of the “Applicable Clinical Trial” needs to be
updated no later than 30 days after the trial is completed.
o “Basic Results” of an “Applicable Clinical Trials” must be reported to
ClinicalTrials.gov no later than one (1) year after the “Primary Completion Date” of
the trial, unless a waiver is granted
If the clinical trial reported here meets the definition of an “Applicable Clinical Trial”
and the Sponsor (or Sponsor-Investigator) of this IND meets the definition of
“Responsible Parties”, then supply the appropriate information for A.1.1.6.1 through
A.1.1.1.6.8.
If the clinical trial reported here DOES NOT meet the definition of an “Applicable
Clinical Trial” and/or the Sponsor (or Sponsor-Investigator) of this IND DOES NOT
meet the definition of “Responsible Parties”, then:
o
o
Delete A.1.1.6.1 through A.1.1.1.6.8, AND
Provide an explanation under A.1.1.6 as to why the trial being reported here does not
meet the definition of an “Applicable Clinical Trial” and/or the Sponsor (Sponsor-
Investigator) of this IND DOES NOT meet the definition of “Responsible Parties”.
SPECIAL CONSIDERATIONS:
o Clinical trials that do not meet the definition of an “Applicable Clinical Trial” can
still be registered and results reported at ClinicalTrials.gov.
• If the trial reported here is registered at ClinicalTrials.gov even though it does not
meet the definition of an “Applicable Clinical Trial”, then supply the appropriate
information for A.1.1.6.1 through A.1.1.1.6.8.
• Note: If the holder of this IND is NOT the Sponsor of the clinical trial, the holder
of this IND should consult with the Sponsor prior to registering or reporting
results at ClinicalTrials.gov.
o
The International Committee of Medical Journal Editors (ICMJE)have specific clinical
trial registration requirements that must be met in order for manuscripts to be
considered for publication in an ICMJE journal, Their requirements include
registration of the clinical trial at ClinicalTrials.gov prior to enrollment of the first
participant. The ICMJE registration information can be found at:
• Statement on Registration:
http://www.icmje.org/publishing_10register.html
• Registration FAQs:
http://www.icmje.org/faq_clinical.html]
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ICTR DDRS: IND Annual Progress Report Guidance and Template for Drug Products Version 3.0
A.1.1.6.1
A.1.1.6.2
A.1.1.6.3
A.1.1.6.4
A.1.1.6.5
A.1.1.6.6
A.1.1.6.7
A.1.1.6.8
NCT Number:
[INSTRUCTIONS: Insert the National Clinical Trial (NCT) Number that was assigned to
the trial at the time that it was registered at ClinicalTrials.gov. If the clinical trial has not
yet been registered, insert “Not Applicable”.]
Date of registration:
[INSTRUCTIONS: Insert the date that the clinical trial was registered at
ClinicalTrials.gov. If the clinical trial has not yet been registered, insert “Not Applicable”.]
Date FDA Form 3674 was submitted to the FDA for this clinical trial:
[INSTRUCTIONS: Insert the date that the FDA Form 3674 was submitted to the FDA for
this clinical trial. If the form has not been submitted, state why it has not been done.
Review the FDA Certification requirement website listed above in the instructions for the
FDA‟s current thinking on when this form should be submitted.]
Date clinical trial information last updated:
[INSTRUCTIONS: Insert the date that the clinical trial information was last updated at
the ClinicalTrials.gov site. If the information has not been updated since the initial
registration, then state „There has been no changes to the clinical trial information since
the trial was initially registered.‟ If the clinical trial has not be registered, insert “Not
Applicable”.]
Date that recruitment information last updated:
[INSTRUCTIONS: Insert the date that the trial recruitment status (e.g., not recruiting,
actively recruiting, open but not actively recruiting, etc…) was updated. If the clinical trial
has not been registered, insert “Not applicable”.]
Primary Completion Date:
[INSTRUCTIONS: Insert the “Primary Completion Date” and indicate whether the date
is the estimated or actual completion date. If the clinical trial has not been registered at
ClinicalTrials.gov, insert “Not Applicable”.]
Date that Basic Results were reported:
[INSTRUCTIONS: Insert the date the “Basic Results” were reported. If the basic
results have not been reported, but the trial is registered at ClinicalTrials.gov and results
are not required to be reported yet, state “The results have not been reported because
the clinical trial has not been completed.” If the clinical trial has not yet been registered,
insert “Not Applicable”.]
Plans for registering if the clinical trial has not yet been registered:
[INSTRUCTIONS: If the clinical trial is required to be registered at ClinicalTrials.gov, but
this has not yet been done, then describe the plan for registering the trial including the
estimated date of trial registration. If the trial has already been registered at
ClinicalTrials.gov, insert “Not applicable.”]
[INSTRUCTIONS: If only reporting one ongoing clinical trial, delete A.1.2 through A.1.2.6.8. If
reporting more than one ongoing clinical trial, continue below with A.1.2. If reporting more than two
ongoing clinical trials, then copy A.1.2 through A.1.2.6.8, paste below A.1.2.6.8 and re-number the
section so that the first three letter/digits read A.1.3., etc.]
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ICTR DDRS: IND Annual Progress Report Guidance and Template for Drug Products Version 3.0
A.1.2
A.1.2.1
A.1.2.2
Trial Title and other identifying information
Title:
Protocol ID Number:
IRB Number:
Purpose of the study:
Study Objectives:
A.1.2.2.1
A.1.2.2.2
A.1.2.3
A.1.2.4
A.1.2.4.1
Primary:
Secondary:
Subject population(s) under study:
Subject Enrollment Status:
Enrollment Time Table
Date study opened to enrollment:
Date enrollment closed:
Expected end date of study:
Months/years open to accrual:
IRB annual approval dates:
A.1.2.4.2
Table of Cumulative Enrollment Summary:
Total planned accrual: ##
Number consented to date: ##
Number enrolled to date: ##
Number completed to date: ##
Number that withdrew/withdrawn from study to date: ##
A.1.2.4.3
Table of Enrollment Summary for this reporting Period
Number consented in this reporting period: ##
Number enrolled in this reporting period: ##
Number that withdrew/withdrawn from study in this ##
reporting period:
Number completed study in this reporting period: ##
A.1.2.4.4
A.1.2.5
Table of Total Number of Enrolled Subjects by Age, Gender, and Race
[INSTRUCTIONS: Note that the same type of table used in A.1.1 should be used to
report the total number of subjects enrolled by Age, Gender, and Race.]
Brief description of available study results:
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ICTR DDRS: IND Annual Progress Report Guidance and Template for Drug Products Version 3.0
A.1.2.5.1
A.1.2.6
A.1.2.6.1
A.1.2.6.2
A.1.2.6.3
A.1.2.6.4
A.1.2.6.5
A.1.2.6.6
A.1.2.6.7
A.1.2.6.8
Publications, Abstracts, Presentations
Registration and Result Reporting at ClinicalTrials.gov:
NCT Number:
Date of registration:
Date FDA Form 3674 submitted to the FDA for this clinical trial:
Date clinical trial information last updated:
Date recruitment information last updated:
Primary Completion Date:
Date Basic Results Reported:
Plans for registering at ClinicalTrials.gov if the trial is not yet registered:
[INSTRUCTIONS FOR THE FOLLOWING SECTION: If reporting on clinical trials that closed during
the reporting period, please complete A.2. If no clinical trials closed during the reporting period, include
a statement under A.2 citing that no clinical trials were closed during the reporting period and delete
A.2.1 through A.2.1.6.7. If reporting more than two closed clinical trials, then copy A.2.1 through
A.2.1.6.7, paste below A.2.1.6.7 and re-number the section so that the first three letter/digits read
A.2.2., etc.]
A.2 Clinical Trials Completed During the Reporting Period
A.2.1
A.2.1.1
A.2.1.2
Trial Title and other identifying information
Title:[INSERT: Title of Protocol]
Protocol ID Number:[INSERT: Protocol ID Number or N/A if none]
IRB Number: [INSERT: IRB Number]
Purpose of the study:
[INSTRUCTIONS: Write a brief description of the purpose of the study.]
Study Objectives:
[INSTRUCTIONS: Describe the study objectives. If there are more than a primary and a
secondary objective, add additional lines.]
A.2.1.2.1
A.2.1.2.2
A.2.1.3
Primary:
Secondary:
Subject population(s) under study:
[INSTRUCTIONS: Describe the study population(s) (e.g., Healthy normal controls, healthy
smokers, schizophrenia, etc…) that will be enrolled in the study.]
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ICTR DDRS: IND Annual Progress Report Guidance and Template for Drug Products Version 3.0
A.2.1.4
A.2.1.4.1
Subject Enrollment Status:
[INSTRUCTIONS:
Provide the information for the tables below.]
If enrollment is closed, or on hold for any reason, include a statement to that effect here
along with an explanation if appropriate.]
Enrollment Time Table
Date study open to enrollment:
Date enrollment closed:
Expected end date of study:
Months/years open to accrual:
IRB annual approval dates:
Study closure date:
[INSERT: Date enrollment closed.]
A.2.1.4.2
Table of Cumulative Enrollment Summary:
Total planned accrual: ##
Number consented to date: ##
Number enrolled to date: ##
Number completed to date: ##
Number that withdrew/withdrawn from study to date: ##
A.2.1.4.3
Table of Enrollment Summary for this reporting Period
Number consented in this reporting period: ##
Number enrolled in this reporting period: ##
Number who withdrew or who were withdrawn from
##
study in this reporting period:
Number completed study in this reporting period: ##
A.2.1.4.4
A.2.1.5
A.2.1.5.1
A.2.1.6
Table of Total Number of Enrolled Subjects by Age, Gender, and Race
[INSTRUCTIONS: Note that the same type of table used in the previous annual report
for a clinical study to report the total number of subjects enrolled by Age, Gender, and
Race should be used so the data is reported consistently, especially in the case of
reporting closed trials.]
Brief description of available study results:
[INSTRUCTIONS: Write a brief description of study data and/or progress]
Publications, Abstracts, Presentations
[INSTRUCTIONS: Provide citations for any of the above in which data from this study
was used.]
Registration and Result Reporting at ClinicalTrials.gov:
[INSTRUCTIONS:
This section of the template is optional as it is not a required by any federal regulation
or FDA guidance document to be included in the IND annual progress report. However,
it is suggested that Sponsor‟s (Sponsor-Investigator‟s) include this section to track
compliance with the Title VIII of the Food and Drug Administration Amendments Act of
2007 (FDAAA) clinical trial registration and reporting requirements.
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Web Resources:
o Definitions of the bolded terms in quotes below can be found at
http://prsinfo.clinicaltrials.gov/definitions.html#RespParty.
o Additional resources pertaining to trial registration and result reporting
requirements can be found at:
• Clinicaltrials.gov Protocol Registration System Information Site
http://prsinfo.clinicaltrials.gov/fdaaa.html.
• NIH Grantees Clinicaltrials.gov and FDAAA Policy Site
http://grants.nih.gov/ClinicalTrials_fdaaa/
• FDA Certification (FDA Form 3674) Guidance (Draft)
http://www.fda.gov/RegulatoryInformation/Guidances/ucm125335.htm
Per Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA),
all “Responsible Parties” must register and report results of certain "Applicable
Clinical Trials."
o “Applicable Clinical Trials” must be registered at ClinicalTrials.gov no later than
21 days after the first patient is enrolled.
o The “Applicable Clinical Trial” information must be updated no less than once
every 12 months, unless there has been no change in the clinical trial information
during the preceding 12-month period.
o The recruitment status of the trial must be updated no later than 30 days after the
status of the trial has changed (e.g. open to accrual, closed to accrual, terminated,
etc.).
o The “Primary Completion Date” of the “Applicable Clinical Trial” needs to be
updated no later than 30 days after the trial is completed.
o “Basic Results” of an “Applicable Clinical Trials” must be reported to
ClinicalTrials.gov no later than one (1) year after the “Primary Completion Date”
of the trial, unless a waiver is granted.
If the clinical trial reported here meets the definition of an “Applicable Clinical Trial”
and the Sponsor (or Sponsor-Investigator) of this IND meets the definition of
“Responsible Parties”, then supply the appropriate information for A.1.1.6.1 through
A.1.1.1.6.8.
Since this clinical trial is listed under the “closed clinical trial” section, then if the trial
meets the registration and reporting criteria, the results from this trial must be reported
to clinicaltrials.gov within 12-months of the “Primary Completion Date”, unless an
extension is requested and granted. For more information about the results reporting
requirements and methods, please review the information posted under the "Basic
Results" Database section “on the “PRS and U.S. Public Law 110-85” website located
at http://prsinfo.clinicaltrials.gov/fdaaa.html.]
A.2.1.6.1
A.2.1.6.2
NCT Number:
[INSTRUCTIONS: Insert the National Clinical Trial (NCT) Number that was assigned
when clinical trial was registered.]
Date of registration:
[INSTRUCTIONS: Insert the date the clinical trial was registered.]
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A.2.1.6.3
A.2.1.6.4
A.2.1.6.5
A.2.1.6.6
A.2.1.6.7
Date FDA Form 3674 submitted to the FDA for this clinical trial:
[INSTRUCTIONS: Insert the date the FDA Form 3674 was submitted for this clinical trial.
If the form has not been submitted, state why it has not been submitted. Review the
FDA Certification requirement website listed above in the instructions for FDA‟s current
thinking on when this form needs to be submitted.]
Date clinical trial information last updated:
[INSTRUCTIONS: Insert the date that the clinical trial information was last updated. If
the information has not been updated since the initial registration, then state „There has
been no changes to the clinical trial information since the trial was initially registered.]
Date recruitment information last updated:
[INSTRUCTIONS: Insert the date that recruitment status (e.g., not recruiting, actively
recruiting, open but not actively recruiting, etc…) was updated.]
Primary Completion Date:
[INSTRUCTIONS: Insert the Primary Completion Date stating that the date is the actual
completion date.]
Date Basic Results Reported:
[INSTRUCTIONS: Insert the date the Basic Results were reported. If the results have
not been reported because the 12-month period between the primary completion date
and the date of the submission of the annual report has not elapsed, then state this and
indicate the expected date the results will be reported to clinicaltrials.gov. If the results
have not been reported due a request for an extension, state this explaining the reason
for the request for an extension and indicate the expected date the results will be
reported to clinicaltrials.gov.]
A.3 Confirmation that clinical trial oversight and monitoring are conducted per the plans
submitted in this IND
[INSTRUCTIONS: Provide a statement confirming that the clinical trial oversight and
monitoring, as outlined in the most recent version of the IND (referred to by IND # serial 0000),
is being performed as described.]
B. Summary Information - Information obtained from clinical and nonclinical investigations
during this reporting period:
B.1 Summary of most frequent and most serious adverse experiences by body system:
[INSTRUCTIONS: Provide a list, in tabular form if possible, of the most frequent and most
serious adverse events by body system. If there were no serious adverse events noted, state
that no serious adverse experiences occurred during this reporting period.]
B.2 Summary of all IND safety reports submitted during the reporting period:
[INSTRUCTIONS: Provide a list of all IND safety reports submitted during the reporting period.
If no reports were submitted, state that no safety reports were submitted.]
B.3 List of subjects who died during participation and cause of death:
[INSTRUCTIONS: Provide a list of all deaths that occurred during participation in the study
during the reporting period along with the cause of death. If no deaths occurred during this
reporting period, include a statement here to that effect.]
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B.4 List of subjects who dropped out during the course of the investigation in association
with any adverse experience, whether or not thought to be drug related:
[INSTRUCTIONS:
Provide a list of all subjects that withdrew or were with withdrawn during the reporting period
from the study due to an adverse experience and state whether or not the experience may
have been due do the drug.
If no subjects withdrew or were withdrawn due to an adverse experience, state that no
subjects withdrew or were withdrawn due to an adverse experience during the reporting
period.
SPECIAL NOTE: If any of the tables labeled “Table of Enrollment Summary for this
reporting period” in section A indicate that a subject withdrew or was withdrawn during this
reporting period, but the withdrawal/removal was not due to an adverse experience, then a
brief statement should be included here explaining the reason for the withdrawal/removal
from the study. For example: “The table in Section A.2.1.4.3 indicates that two subjects
withdrew during this reporting period; however, neither withdrew because of an adverse
experience. One of the participants withdrew because he moved out of state with his job and
the other cited child care changes that decreased the amount of time that she could devote
to study visits”.]
B.5 Summary of information obtained pertinent to understanding the drug's actions (dose
response, bioavailability, information from other controlled trials, etc.):
[INSTRUCTIONS: Provide a summary of any pertinent information obtained during the
reporting period concerning the understanding of the drug‟s action. If no new information has
been obtained, include the following statement: “No pertinent information concerning the drug‟s
action was obtained during this reporting period.”]
B.6 List of preclinical studies (including animal studies) completed or in progress during the
reporting period and a summary of major preclinical findings:
[INSTRUCTIONS: List ALL preclinical studies in progress or completed during this reporting
period along with a summary of any major findings. SPECIAL NOTE: While not required, it is
suggested that the primary objective of each study be included within the list.]
B.7 Summary of any significant manufacturing or microbiological changes made during the
reporting period:
[INSTRUCTIONS:
Provide a summary describing any significant manufacturing or microbiological changes
made during the reporting period. Changes may include but are not limited to:
o Updated information (i.e. lot release data and characterization testing in tabular form
as in original CMC section) on any newly produced clinical lots
o Updated stability information
o Updated information on analytical methods
o Updated manufacturing quality control and quality assurance processes
If there were no significant changes made, include a statement here to that effect.]
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ICTR DDRS: IND Annual Progress Report Guidance and Template for Drug Products Version 3.0
C. Description of the general investigational plan for the upcoming reporting period
(coming year) to replace the plan submitted with the last annual report:
[INSTRUCTIONS: Describe what changes are being considered to the general investigational
plan for the upcoming year to replace the previous year‟s plan. If changes are being made,
please use the following format. If no changes are planned, include a statement to that effect
here, including an explanation as to why, and delete E.1 through E.6.]
C.1 Rationale for the investigational drug or the research study (studies):
C.2 Indication(s) to be studied:
C.3 General Approach to be followed in evaluating the investigational drug:
C.4 Types of clinical studies to be conducted in the upcoming reporting period:
[SPECIAL NOTE: If plans have not been developed for the entire year, include a statement here
to that effect. In this instance, an additional statement should be made citing that appropriate
protocol amendments will be submitted to the FDA as these plans are developed.]
C.5 Estimated number of patients or subjects who will be administered the investigational
drug under these studies during the upcoming reporting period:
C.6 Anticipated significant risks of study participation:
[SPECIAL NOTE: Describe any risks of particular severity or seriousness anticipated on the
basis of preclinical toxicology studies or prior clinical studies of the investigational drug or
related drugs. If no significant risks are anticipated, include a statement here to that effect.]
D. Description of any revisions to the Investigator's Brochure as well as a copy of the newly
revised Brochure:
[INSTRUCTION:
If the investigator‟s brochure was revised, describe the revision(s) and provide a copy of
the new brochure in the appendix.
If no revisions were made during the reporting period, include a statement here to that
effect.
If there is no investigator brochure for this IND, include a statement here to that effect.
If the IND is for an approved drug, indicate whether or not any changes were made to
the approved package insert during the reporting period and include a copy of the
updated package insert in the appendix.
o Note that the National Library of Medicine now maintains a reference website of
approved package inserts at: http://dailymed.nlm.nih.gov/dailymed/about.cfm.]
E. Describe any significant Phase I protocol modifications made during the reporting period
which have not been previously reported to the FDA in a protocol amendment:
[INSTRUCTIONS:
List all protocol modifications that were made during the reporting period which were not
reported to the FDA in a Protocol Amendment: Change in Protocol submission.
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o
o
o
If unreported modifications were made, include a statement here to that effect,
explaining that a copy of the revised protocol and consent form, if applicable,
is/are attached for FDA review in the appendix.
SPECIAL NOTE: Per 21CFR312.30 (b), certain changes need to be reported to
FDA and IRB approved prior to implementation. If changes were made to the
protocol that fall under the categories listed in 312.30(b), an explanation as to
why the changes were not reported in a timely manner must be included here.
The website for 21CFR312.30 (b) can be found at:
• http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=312.30
Note: If changes were made to more than one open protocol under this IND in
this reporting period, list the changes by protocol, for example “G.1 For study A.#
above, entitled “Protocol Title,” the following amendment was made to the
protocol.”
If no protocol modifications were made during the reporting period, include a statement
here to that effect.]
F. Summarize any significant foreign marketing developments with the drug during the
reporting period:
[INSTRUCTIONS: Provide a brief summary of any known foreign marketing changes for the
drug that were made during this reporting period. Changes can include, but are not limited to,
approval of a marketing application in any country or withdrawal or suspension from marketing
in any country. If there were no known foreign marketing developments during the reporting
period, include a statement here to that effect.]
G. Log of any outstanding IND related business to which a reply, comment or scheduled
meeting with FDA is expected or requested:
[INSTRUCTIONS: Describe all outstanding business with the FDA related to this IND. If there is
no outstanding business, include a statement here to that effect.]
H. Attachments:
[INSTRUCTIONS: Provide a list of all attachments being submitted with this annual progress
report. If no attachments are being submitted, include a statement here that there are no
attachments being submitted.]
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