**[Clinical Center Prospective Protocol Resource Assessment
Tool]{.smallcaps}**

Protocol Title:

  -------------------------------------- --------------------------------
                                         

  **[Principal Investigator, Institute        
  and Branch:]{.smallcaps}**             
  -------------------------------------- --------------------------------

  -----------------------------------------------------------------------
  **This tool is to be completed by principal investigators and should be
  submitted to the CC Office of the Director immediately following
  scientific review. The completed form will be disseminated to CC
  Department Heads to facilitate early interaction with investigators to
  assess recourse requirements while the protocol is in the human
  subjects review process. The goal of this review is to assure that
  resource intensive protocols are identified early in the process and
  that only necessary test and procedures are built into the protocol
  design.**

  -----------------------------------------------------------------------

**[Clinical Status of Patients]{.smallcaps}**

***Functional Status of Patients (Check one)***

> Completely Independent -- no physical limitations
>
> Some limitations, uses aids for mobility, may require adaptation in
> hospital environments
>
> Require assistance/supervision
>
> Dependent for basic Activities of Daily Living (ADL)
>
> Require complete care

***Disease Process (Check one)***

> None -- Healthy volunteers/or remission state
>
> Stable, no unstable comorbidities
>
> Stable, but may have comorbidities
>
> Unstable, advanced or progressed disease which may worsen
>
> Critical/multisystem involvement

***Social Issues (Check all that apply)***

> Family support needs (children accompanying family, lodging,
> recreation therapy, etc.)
>
> Targeting international patients
>
> Need for means evaluation for travel support
>
> Language barriers/translation requirements/communication device needs
>
> Targeting underserved populations with limited resources
>
> Complex discharge planning
>
> Employment re-entry issues or vocational retraining
>
> Significant end of life care issues (Nursing, Pain and Palliative
> Care, Pharmacy)

+----------+-----------------------------------------------------------+
| > Other  |                                                           |
+----------+-----------------------------------------------------------+

***Anticipated Clinical/Diagnostic Procedures (Check all that apply)
[Projected Volume]{.underline}***

+----------+----------------------------------------+-----------------+
| >        |                                        |                 |
| > Ou     |                                        |                 |
| tpatient |                                        |                 |
| >        |                                        |                 |
| surgical |                                        |                 |
| > pr     |                                        |                 |
| ocedures |                                        |                 |
+----------+----------------------------------------+-----------------+
| >        |                                        |                 |
| >        |                                        |                 |
| Invasive |                                        |                 |
| > (en    |                                        |                 |
| doscopy, |                                        |                 |
| > bronc  |                                        |                 |
| hospopy, |                                        |                 |
| > co     |                                        |                 |
| lonscopy |                                        |                 |
| > etc.)  |                                        |                 |
+----------+----------------------------------------+-----------------+
| >        |                                        |                 |
| > Pr     |                                        |                 |
| ocedures |                                        |                 |
| > r      |                                        |                 |
| equiring |                                        |                 |
| > c      |                                        |                 |
| onscious |                                        |                 |
| >        |                                        |                 |
| sedation |                                        |                 |
| >        |                                        |                 |
|  outside |                                        |                 |
| > the OR |                                        |                 |
+----------+----------------------------------------+-----------------+
| >        |                                        |                 |
|  Surgery |                                        |                 |
| > r      |                                        |                 |
| equiring |                                        |                 |
| > post-o |                                        |                 |
| perative |                                        |                 |
| >        |                                        |                 |
| hospital |                                        |                 |
| > stays  |                                        |                 |
+----------+----------------------------------------+-----------------+
| >        |                                        |                 |
| > E      |                                        |                 |
| xtensive |                                        |                 |
| > be     |                                        |                 |
| havioral |                                        |                 |
| > ass    |                                        |                 |
| essments |                                        |                 |
+----------+----------------------------------------+-----------------+
| >        |                                        |                 |
| > Ce     |                                        |                 |
| ntral/Pe |                                        |                 |
| ripheral |                                        |                 |
| > line   |                                        |                 |
| > i      |                                        |                 |
| nsertion |                                        |                 |
| >        |                                        |                 |
| mandated |                                        |                 |
+----------+----------------------------------------+-----------------+
| >        |                                        |                 |
|  Cardiac |                                        |                 |
| > mo     |                                        |                 |
| nitoring |                                        |                 |
| >        |                                        |                 |
| mandated |                                        |                 |
+----------+----------------------------------------+-----------------+
| > High   |                                        |                 |
| > pro    |                                        |                 |
| bability |                                        |                 |
| > for    |                                        |                 |
| > in     |                                        |                 |
| fectious |                                        |                 |
| >        |                                        |                 |
|  disease |                                        |                 |
| > i      |                                        |                 |
| solation |                                        |                 |
+----------+----------------------------------------+-----------------+
| >        |                                        |                 |
| > Fu     |                                        |                 |
| nctional |                                        |                 |
| >        |                                        |                 |
|  Outcome |                                        |                 |
| >        |                                        |                 |
| Measures |                                        |                 |
+----------+----------------------------------------+-----------------+
| > Serial |                                        |                 |
| >        |                                        |                 |
| sampling |                                        |                 |
| > of     |                                        |                 |
| > blood  |                                        |                 |
| > or     |                                        |                 |
| > other  |                                        |                 |
| > fluids |                                        |                 |
+----------+----------------------------------------+-----------------+
| >        |                                        |                 |
| >        |                                        |                 |
|  Pharmac |                                        |                 |
| okinetic |                                        |                 |
| >        |                                        |                 |
|  studies |                                        |                 |
+----------+----------------------------------------+-----------------+
| >        |                                        |                 |
|  Complex |                                        |                 |
| >        |                                        |                 |
|  imaging |                                        |                 |
| >        |                                        |                 |
|  studies |                                        |                 |
| > (r     |                                        |                 |
| equiring |                                        |                 |
| >        |                                        |                 |
|  patient |                                        |                 |
| > prep,  |                                        |                 |
| > nurse, |                                        |                 |
| > acco   |                                        |                 |
| mpanying |                                        |                 |
|          |                                        |                 |
| patient  |                                        |                 |
| to       |                                        |                 |
| imaging  |                                        |                 |
| study,   |                                        |                 |
| etc.)    |                                        |                 |
+----------+----------------------------------------+-----------------+
| > Other  | [     ]{.underline}                    |                 |
+----------+----------------------------------------+-----------------+

***Critical Care (Check all that apply)***

> High Risk for medical or surgical ICU (i.e., anticipate that \>5% of
> patients will require ICU Care)
>
> Expected use for intermediate care
>
> Nuclear cardiology procedures
>
> ***Pharmacy (Check all that apply)***
>
> Protocol involves the off-label use of marketed drug research.
>
> For protocols where the object of study is the off-label use of a
> marketed drug, the pharmaceutical
>
> company has been contact to seek no-cost drugs.
>
> Protocols will involve high medication needs outside of protocol
> constructs due to comorbidities or

disease entity (e.g. CHF, asthma, transplant patients, etc.)

> All drugs in the study are on the CC formulary.
>
> Alternative drug substitutes can be utilized in the protocol (Pharmacy
> will be consulted).
>
> Significant supportive therapy based on protocol treatment (TPN,
> chemotherapy, etc.)
>
> Supportive care and "non-study" medications (e.g. pain medications,
> antiemetics, antibiotics, growth

factors) are selected, dosed and monitored based on current evidence
practice guidelines.

  ------------- ---------------------------------------------------------
  Cite               
  guideline:    

  ------------- ---------------------------------------------------------

> Medications in protocol use CC standard administration times, diluent
> volumes for IV's and standard

clinical doses.

***[Imaging Science (Check all that apply) Projected
Volume]{.underline}***

+----------------------------------------------------+-----------------+
| > CT Scans                                         |                 |
+----------------------------------------------------+-----------------+
| > MRI scans                                        |                 |
+----------------------------------------------------+-----------------+
| > PET scans                                        |                 |
+----------------------------------------------------+-----------------+
| > Interventional Studies                           |                 |
+----------------------------------------------------+-----------------+

***Transfusion Medicine (Check all that apply) [Projected
Volume]{.underline}***

+----------------------------------------------------+-----------------+
| > Cell processing service requirements             |                 |
+----------------------------------------------------+-----------------+
| > Apheresis service-cellular therapy product       |                 |
| > collections                                      |                 |
+----------------------------------------------------+-----------------+
| > Therapeutic apheresis (photopheresis, LDL        |                 |
| > apheresis, plasma or red                         |                 |
| >                                                  |                 |
| > cell exchanges)                                  |                 |
+----------------------------------------------------+-----------------+
| > Surgical procedures requiring \>6 blood products |                 |
| > per case                                         |                 |
+----------------------------------------------------+-----------------+
| > Advanced molecular testing for HBV, HCV, or HIV  |                 |
| > (Genotype,                                       |                 |
| >                                                  |                 |
| > quantitative PCR)                                |                 |
+----------------------------------------------------+-----------------+
| > Red cell reference testing (phenotypes, DAT or   |                 |
| > antibody titers)                                 |                 |
+----------------------------------------------------+-----------------+
| > HLA sequence based typing                        |                 |
+----------------------------------------------------+-----------------+
| > High volume HLA typing (\>200 typings per year)  |                 |
+----------------------------------------------------+-----------------+
| > HLA haplotype interpretative information         |                 |
+----------------------------------------------------+-----------------+
| > Other specialized HLA typing (DPB/DQA, KIR)      |                 |
+----------------------------------------------------+-----------------+

> ***[Laboratory Medicine (Check all that apply) Projected
> Volume]{.underline}***

+----------------------------------------------------+-----------------+
| > HIV viral load testing                           |                 |
+----------------------------------------------------+-----------------+
| > Bone marrow testing                              |                 |
+----------------------------------------------------+-----------------+
| > Chimerism testing (bone marrow transplant        |                 |
| > program only)                                    |                 |
+----------------------------------------------------+-----------------+
| > Hematology flow cytometry (specialized tests for |                 |
| > PNH and myeloid                                  |                 |
| >                                                  |                 |
| > cells)                                           |                 |
+----------------------------------------------------+-----------------+
| > Immunology flow cytometry (other than CD4 and T, |                 |
| > B, NK tests)                                     |                 |
+----------------------------------------------------+-----------------+
| > PCR based microbe testing                        |                 |
+----------------------------------------------------+-----------------+
| > Fungal antigen testing                           |                 |
+----------------------------------------------------+-----------------+
| > Specialized (off-site) reference laboratory      |                 |
| > tests                                            |                 |
+----------------------------------------------------+-----------------+

> ***[Nutrition (Check all that apply) Projected Volume]{.underline}***

+----------------------------------------------------+-----------------+
| > Special foods or formulas (specify types)        |                 |
+----------------------------------------------------+-----------------+
| > Special diet (research, test or metabolic diets  |                 |
| > -- specify types)                                |                 |
+----------------------------------------------------+-----------------+
| > Body composition measurements or food records    |                 |
| > (specify)                                        |                 |
+----------------------------------------------------+-----------------+
| > Patients requiring nutritional counseling or     |                 |
| > education (specify)                              |                 |
+----------------------------------------------------+-----------------+

> ***[Rehabilitation Medicine (Check all that apply) Projected
> Volume]{.underline}***

+----------------------------------------------------+-----------------+
| > Mobility/balance, physical impairments or        |                 |
| > assistive needs                                  |                 |
+----------------------------------------------------+-----------------+
| > Difficulties with swallowing, speech, language   |                 |
| > or cognition                                     |                 |
+----------------------------------------------------+-----------------+
| > Significant musculoskeletal or neuropathic pain  |                 |
+----------------------------------------------------+-----------------+
| > Extensive recreational and/or socialization      |                 |
| > needs                                            |                 |
+----------------------------------------------------+-----------------+
| > Vocational Rehabilitation Services               |                 |
+----------------------------------------------------+-----------------+