(To be completed by BIPI: Tracking #______Date______) ABCD

External Collaborative Research Application Form

Instructions:

Applicants may choose to submit either a brief study synopsis, full study proposal or a study protocol for evaluation of External Collaborative Research grant support. BIPI does not have a preference and will review all submissions received.

·  For synopsis submissions, please complete the following sections 1 2, and sign and date the application. Please also provide supportive literature citations and a signed/dated CV. If you choose this option, BIPI will review and confirm strategic interest, after which we will request completion of section 3 (full proposal).

·  For proposal submissions, please complete the following sections 1-3, and sign and date the application. Please also include detailed budget information (BIPI does not require a specific format), supportive literature citations and provide a signed/dated CV.

·  For protocol submissions, please complete section 1 and submit your full written protocol (BIPI does not require a specific format), and sign and date the application. Please also include detailed budget information (BIPI does not require a specific format), supportive literature citations and a signed/dated CV.

All completed applications can be submitted to the following mailbox:

. We will email you confirmation of receipt within 48 hours.

For any questions about the application process, please contact your assigned Medical Science Liaison or send an email to .

Section 1- Administrative Information

Principal Investigator

Title

Organization
Department
Address
Phone
Fax
E-mail
Any additional staff to be cc’ed (e.g. study coordinator, administrative assistant)
Study Title
Study Type (pre-clinical, interventional, non-interventional)
Number of sites /  Monocenter -Study
 Multicentre-Study, n = ____
 Multinational Study, countries = ______(please list)

Required Support

/ q Financial Support
q Study drug originated by BI
q Other (please specify): ......

Please read and acknowledge the following statements:

·  I understand that External Collaborative studies supported by BI must follow all relevant International and National laws, as well as applicable ethical and scientific guidelines, (e.g., ICH E6, GCP Compliance Guideline).

·  I will deliver adverse events to BIPI in accordance with local regulatory and BI global reporting requirements.

·  I have attached a signed/dated CV

·  I have provided supportive literature citations as an attachment

Signature of Principal Investigator

______

[Please insert place and date] [Please insert name]
Principal Investigator

External Collaborative Research Application Form

Section 2- Synopsis of Research

BI Study Substance to be studied
Therapeutic Area /  Metabolism (Diabetes)
 Cardiovascular
 Respiratory
 Oncology
Non-BI drug(s) as part of the study (as applicable)
Disease State / Indication
Please state the medical condition of the patients being studied/indication for treatment.
Also indicate the stage which best characterizes patients to be enrolled in this study, if applicable.
Study Phase
/  Phase I
 Phase II
 Phase III
 Phase IV
 Preclinical
 Not Applicable: please describe:______
Medical/Scientific Rationale
Please provide the reason for conducting the study based on current knowledge and existing data; please also provide cited references to support this rationale. / (attach supportive literature citations at end of application)
Study Objective
Hypothesis to be generated or tested. A concise statement of the major and minor questions that the trial is designed to answer in order of importance or relevance.
Primary and Secondary Endpoints:
The primary endpoint should be capable of providing the relevant and convincing evidence to address the primary objective (hypothesis). In general the primary efficacy endpoint should reflect accepted norms in practice and be both reliable and standardized.
Secondary endpoints may either be supportive of the primary objective or address the secondary objectives (hypothesis) under study. The number of secondary endpoints should be limited to the number of outcomes under study
Study Overview:
Provide a brief explanation of the experimental design including the disease to be treated, its stage and line of treatment (if applicable), randomization (if any), controls or comparator drugs (if any), approx. number of subjects to be enrolled, involvement of multiple institutions, number of study visits and estimated duration of study from first patient in to first results available.


External Collaborative Research Application Form

Section 3- Full Proposal Details

Names, address and contact details of additional sites (if available)
Study Design
Please select all that apply /  Prospective
 Retrospective
 Randomized
 Non-Randomized
 Non-Controlled
 Placebo-Controlled
 Comparator-controlled
 Blinded
 Open-label
 Parallel arm--please indicate number of arms n=____
 Cross-sectional
 Cross –over
 Exploratory / Pilot
 Confirmatory
 Other, please describe:______
Inclusion Criteria
In designing Inclusion and Exclusion criteria it is important to include criteria that would ensure scientific validity and exclude subjects from enrollment who might be put at unacceptable risk. Eligibility criteria should support scientific rationales and address any regulatory issues and practical concerns; should be straightforward and unambiguous. Please include any testing/lab values that will also be used in the final protocol for inclusion.
Exclusion Criteria
In determining exclusion criteria for drug studies, the author is referred to the product investigational brochure or package labelling regarding known safety considerations and contraindications to drug treatment

Treatment Plan and Dosing Regimen, including planned visit schedule

The study design should provide an explanation of the experimental design and contain a brief stepwise description of all procedures required by the study. Please consider initial evaluations, screening tests, non-standard of care lab tests, details of treatment intervention and ancillary procedures, as well as dose scheduling, modification, and appreciation for study visits. A study flow chart is highly recommended. It should display timing of planned interventions as well as all clinical and laboratory measurements and the time periods (e.g., hours, days, weeks) at which data are to be collected.
Please attach a study flow chart with this application if appropriate.
Please also consider:
·  Treatment plan and therapeutic goals
·  Comparator treatment products (if applicable)
·  Dosage and dosing regimen for all study periods
·  Route of administration for study products
·  Blinding techniques (if applicable)
Study Drug Strength and Quantities:
Please detail the drug required for the study and the quantity needed. Please include any detail on packaging requests.

Is any Translational Research planned?

If yes, please describe- quality of life, PK, Biomarkers etc.

/  No
 Yes: please describe below:______

Number of Subjects and Power Calculation

·  Sample size (total)
·  Number of patients per treatment arm
A power calculation needs to be included that substantiates the target enrolment needed to show detectable difference relative to the primary hypothesis. This calculation should take the form of a comprehensive summary that includes assumptions. Checklist for statistics:
1. (One-sided or two-sided) alpha
2. Power or beta
3. Expected effect size for control treatment (based on historical control with reference, e.g. median PFS, median OS, objective response rate, etc., depending on primary endpoint)
4. Expected effect size for experimental treatment (e.g. expected/relevant hazard ratio or median PFS (OS), response rate, etc., of experimental treatment)
5. Used test/design (e.g. Log-rank test, binomial test, Simon-two stage design, etc.)

Statistical Methods

·  Statistical approach
·  Primary study population (FAS, PPS, other)
·  Interim analysis (if applicable)
All planned primary analyses and key secondary analyses should be discussed in this section. If other secondary and tertiary analyses are planned, then a statement should be included in this section as to what these analyses are. Describe in detail the statistical methods that will be used for the primary hypotheses or estimation. State the statistical tests which will be used (e.g., ANOVA, Kaplan‐Meier) along with other important considerations (e.g., factors in ANOVA, pre‐specification of covariates, strata for Mantel‐Haenszel, use of historical controls).
Study Duration and Timelines
Best case scenario based on feasibility
CTA= Clinical Trial Agreement signed
FPI= First Patient in
LPI=Last Patient In
LPO= Last Patient Out
LPLV= Last Patient Last Visit
CTR= Clinical Trial report /
Months per step / Months Cumulitive
CTA to FPI
FPI to LPI
LPI to LPO
LPO to LPLV
LPLV to Database Lock
Database Lock to CTR
CTR to Publication
Publications / Planned # of Abstracts: ______
Planned scientific meeting(s) under consideration for presenting study results:______
# of Anticipated Manuscripts: ______
Target date for submission:______
(primary manuscript)
Name(s) of Journal(s):______

Study Budget

Please add detailed budget plan as appendix to this study outline as an excel spreadsheet

/ Personnel Costs: (please indicate % effort also)
As applicable, please detail costs for:
Research Nurse
Study Coordinator
Safety Support
Statistical Support
Study Monitor
Data Manager
Regulatory Support
Other
Total Study Personnel Costs:______
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Other Costs:
As applicable, please detail costs for:
Regulatory Fees
Pharmacy Fees/ Study Medication
Data Management
Translational Research
Laboratory/Diagnostic
Clinic Costs
Publications
Institution Overhead
Other Administrative Fees
Total Other Costs:______
------
Total Study cost:______
Per subject cost:______
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Number of Sources of Funding (other than BI):______
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Total funding requested from BI______

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