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					                                                                                                           SPONSOR STUDY BUDGET



CLINICAL TRIALS SPONSOR STUDY BUDGET                                        TEMPLATE / 2006                                              *****SAMPLE BUDGET*****
                                                                                                                                        Note to PI/Coordinator - the below
                                                                                                                                        costs are examples. Your budget
                                                                                                                                        should reflect what is needed for your
University of Tennessee Health Science Center                                                                                           particular study.
                                                                                                                                        UTHSC, Clinical Trials
                                                                                                                                        901-448-3126
                                                          BUDGET PROPOSAL - SAMPLE
                               Principal Investigator:
                                  Study Coordinator:
                                            Sponsor:
                                                 Title:
                                       IRB Number:

START UP BUDGET                                           COST PER UNIT UNITS TOTAL COST
Investigator Protocol Review                                         750     1         750
Site Feasibility Visit                                               400     1         400
Investigator at Inv. Meeting ($750 per day)                          750     2       1500                 includes days traveling
Coordinator at Inv.Meeting ($400 per day)                            400     2         800                includes days traveling
IRB Submission/Regulatory Doc Prep                                  3000     1       3000
Investigation Pharmacy fee                                          1000     0           0
Total                                                                                6,450 *                1612.50 per patient


FIXED STUDY BUDGET                                        COST PER UNIT UNITS TOTAL COST
IRB FEE                                                             2000     1       2000 To be invoiced/pass through
Total                                                                                2000

FIXED STUDY BUDGET
Advertising (irb prep/sbumission plus ad process)                     500        1            500         This is for onset ads, addtitional ads would be billed separately.
Study Initiation Visit ($50 per Hour)                                  50        4            200         based on a 3 hrs coord time with one hour of prep time
Study Close-Out ($50 per Hour)                                         50        4            200         based on a 3 hrs coord time with one hour of prep time
Monitoring visits (estimated number of visits)                        200        4            800         if monitoring visits exceed this number, then charge for them separately
SAE Submissions estimated                                             400        3          1200          if more than 3 SAE's, bill for additonal
IND Submissions (first 6)                                              50        6            300         after 6 IND reports, bill for each additional
IRB Annual renewal (estimate 4 years)                                 250        4          1000          if more than 4 years, bill for additional years at the going rate at that time
Record Storage                                                        500        1            500         record storage is likely better billed by the box at the end of the trial
Screen Failures (first 8)                                             250        8          2000          if more than 8 screen failures, bill for additonal
Total                                                                                      6,700             1675.00 per patient


PER SUBJECT BUDGET
Procedure\Labs                                            COST PER UNIT UNITS        TOTAL COST Visit 1 Visit 2         Visit 3
                                                                                                  Screen PK Day         24 Hr
Informed consent                                                      150        1            150       1
Inclusion/Exclusion                                                    50        2            100       1           1
Medical/Interval History                                               75        1             75       1
Physical Examination                                                  250        1            250       1
Brief Physical                                                         50        2            100                   1               1
Lab Specimen                                                           75        3            225       1           1               1
Urine Preg Test                                                        50        2            100       1           1
Vital Signs                                                            30        3             90       1           1               1
2 Hr Sustacal                                                          75        1             75       1
PK Sampling                                                            50        9            450                   8               1
AE's                                                                   50        2            100                   1               1
Con Meds                                                               50        3            150       1           1               1
Pharmacy fee                                                           30        1             30       1
Investigator fee                                                      150        3            450       1           1               1
CRF Transcription                                                      25        5            125       2           2               1
Research Nurse (visit, hr)                                             50       16            800       2          13               1
Research Unit Room Charge                                              50       16            800       2          13               1
Patient Reimbursement                                                  25        9            225       1           7               1
Total                                                                                      4,295

                 STUDY BUDGET
                                                          Per Subject      # Ppts   TOTAL
Total Per Subject                                                 4,295.00        4       17,180
Start up Costs                                                    1,612.50                 6,450 *
Fixed Costs                                                        1675.00                 6,700

Subtotal                                                          7,582.50                 30,330

CRO Administrative Charge 10-20%                                                                0
UT OVERHEAD 20%                                                  1,516.50                   6,066

STUDY TOTAL                                                    9,099.00          4        36,396
IRB Fee                                                                                     2,000 (PASS THROUGH)
GRAND TOTAL                                                                             $38,396

*Note: Startup Charges are nonrefundable


Variable Costs-billable as they occur
SAE (per occurrence $500) after first 3 SAE's
IND Safety Report (per occurrence $75) after first 10 IND's
Screen Failure (per occurrence $250 ) after first 8
Additional Advertising (per submission $200) plus cost pass-through
IRB Annual Renewal (per submission $250)
Amendment Submission (per submission $750)
Administrative Letter or Clarification Submission (per submission $350)
Chart Request (per chart $25)                                                                                                           you could absorb this cost in Mornitoring Visits
Monitoring Visit (per day $200) based on coordinator time spent with monitor of 3 hours or less per day                                 includes cost of chart requests, prep for visit and visit follow-up
FDA Audit (coordinator time billed at $50 per hour)
Sponsor Audit (coordinator time billed at $50 per hour)
Record Storage $30 per year per box                                                                                                     when do storage costs begin?


Contract language should specify that payments
are for obtaining either data that exists through
standard of care or data that is generated
separately through research-initiated acitivities or
procedures. The payment for the data may be the
same, regardless of the origin of the data OR the
payment for the data may be the same with an
additional payment (usually this is then a pass
through) to cover the cost of the research-inititated
activities or procedures.




                                                                                                                                                                                                       27790ea6-891d-497f-99dd-77e640a2237c.xls

				
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