untitled h1
cris chemotherapy/biotherapy treatment note

| For patients WITHOUT a  prior H/O HSR                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       | For Step 1 HSR Interventions   | For Step 2 HSR Interventions   | For Step 3 HSR Interventions   |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|--------------------------------|--------------------------------|
| Docetaxel                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   | _______ mg/m2                  |                                |                                |
| (calculated                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 | dose                           | =                              |                                |
| _______ mg) IV over 60 min                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  | Docetaxel                      | _______ mg/m2                  |                                |
| (calculated dose = _______ mg)  IV over 1 - 2 hours                                                                                                                                                                                                                                                                                                                                                                                                                                                                         | Docetaxel                      | _______ mg/m2                  | (calculated                    |
| TOTAL dose = _______ mg) continuous IV  infusion over 2 hours, every 2 hours for  2 doses                                                                                                                                                                                                                                                                                                                                                                                                                                   | Docetaxel                      | _______ mg/m2                  | (calculated                    |
| TOTAL dose = _______ mg) given in  3 portions, as follows: #1 of 3: Docetaxel 5 mg IV over  60 minutes #2 of 3: Docetaxel 25 mg IV over  60 minutes #3 of 3: Docetaxel _______ mg  (calculated TOTAL dose minus 30 mg  from products #1 & #2, above) IV over  2 hours                                                                                                                                                                                                                                                       |                                |                                |                                |
| Because patient, ____________________, has a history of hypersensitivity reaction with docetaxel administration, they will  receive pre-medication and docetaxel according to Step #_______ of the guidelines for Prophylaxis and Treatment for  Hypersensitivity Reactions (HSR) Associated with Docetaxel.                                                                                                                                                                                                                |                                |                                |                                |
| In the event of a hypersensitivity reaction associated with docetaxel administration: 1. Immediately STOP docetaxel administration. 2. Rapidly administer PRN doses of hydrocortisone & diphenhydramine. 3. Assess patient to determine whether additional PRN meds are indicated. 4. Reinitiate docetaxel after hypersensitivity signs and symptoms have completely resolved. 5. In the event of a hypersensitivity reaction, contact: Dr. ______________________________at 102-____________. Anna Couvillon at 102-10744. |                                |                                |                                |  
113 CTEP Study \#: 9243  
| For patients WITHOUT a prior H/O HSR       | For Step 1 HSR                                  | For Step 2 HSR  Interventions                       | For Step 3 HSR Interventions   |
|--------------------------------------------|-------------------------------------------------|-----------------------------------------------------|--------------------------------|
| Interventions                              |                                                 |                                                     |                                |
| Dexamethasone 8 mg PO for 3 doses at 12 h, | Dexamethasone 8 mg PO for 2 doses at 12 h & 3 h | Dexamethasone 8 - 20 mg PO for 2 doses between 24 - |                                |
| 3 h, & 1 h before starting docetaxel       | before starting docetaxel                       | 36 h and at 12 hours before starting docetaxel      |                                |
untitled h1
17.4 appendix d ccr patient

This form is to be updated at every study contact where patient receives or returns study drug. This form may be used for multiple selfadministered study agents. This form is to be used in conjunction with a note in CRIS about study drug self-administration and case report form  
  
and will be maintained in the research record. If patient is bringing back their study drug and you will not be returning that to the pharmacy, rather, the patient will be taking it back home with them, please use the form entitled '*CCR Patient Self-Administered Study Agent Interim* Compliance Form'.  
| CC Protocol Number:_________________________                                                                                                                                                                                                      | Principal Investigator:______________________   |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|
| Protocol Title:_____________________________________________________________________________ Patient's Medical Record Number:____________________ Patient's Name:___________________________ Patient Study ID: ________________ Cycle Number_____ |                                                 |  
| Date Dispensed                                               | Amount               | Dose Form                |                         |                            |                       |
|--------------------------------------------------------------|----------------------|--------------------------|-------------------------|----------------------------|-----------------------|
| Dispensed                                                    | Date Returned        | Actual  Amount  Returned | Expected  Amount  Taken | Expected  Amount  Returned | Reason for difference |
| between actual and expected  amount returned, if  applicable | Site Staff  Initials |                          |                         |                            |                       |
| (e.g., tablets,  pills, bottles,  capsules, vials)           |                      |                          |                         |                            |                       |
| ____/_____/20_____                                           | ____/_____/20______  |                          |                         |                            |                       |
| (mm/dd/yyyy)                                                 | (mm/dd/yyyy)         |                          |                         |                            |                       |
| ____/_____/20_____                                           | ____/_____/20______  |                          |                         |                            |                       |
| (mm/dd/yyyy)                                                 | (mm/dd/yyyy)         |                          |                         |                            |                       |
| ____/_____/20_____                                           | ____/_____/20______  |                          |                         |                            |                       |
| (mm/dd/yyyy)                                                 | (mm/dd/yyyy)         |                          |                         |                            |                       |
| ____/_____/20_____                                           | ____/_____/20______  |                          |                         |                            |                       |
| (mm/dd/yyyy)                                                 | (mm/dd/yyyy)         |                          |                         |                            |                       |  
115 CTEP Study \#: 9243  
| Date Dispensed                                               | Amount               | Dose Form                |                         |                            |                       |
|--------------------------------------------------------------|----------------------|--------------------------|-------------------------|----------------------------|-----------------------|
| Dispensed                                                    | Date Returned        | Actual  Amount  Returned | Expected  Amount  Taken | Expected  Amount  Returned | Reason for difference |
| between actual and expected  amount returned, if  applicable | Site Staff  Initials |                          |                         |                            |                       |
| (e.g., tablets,  pills, bottles,  capsules, vials)           |                      |                          |                         |                            |                       |
| ____/_____/20_____                                           | ____/_____/20______  |                          |                         |                            |                       |
| (mm/dd/yyyy)                                                 | (mm/dd/yyyy)         |                          |                         |                            |                       |
| ____/_____/20_____                                           | ____/_____/20______  |                          |                         |                            |                       |
| (mm/dd/yyyy)                                                 | (mm/dd/yyyy)         |                          |                         |                            |                       |
| ____/_____/20_____                                           | ____/_____/20______  |                          |                         |                            |                       |
| (mm/dd/yyyy)                                                 | (mm/dd/yyyy)         |                          |                         |                            |                       |
untitled h1
17.5 appendix e ctep multicenter

If an institution wishes to collaborate with other participating institutions in performing a CTEP sponsored research protocol, then the following guidelines must be followed.
untitled h1
responsibility of the protocol chair

- The Protocol Chair will be the single liaison with the CTEP Protocol and Information Office
(PIO). The Protocol Chair is responsible for the coordination, development, submission, and approval of the protocol as well as its subsequent amendments. The protocol must not be rewritten or modified by anyone other than the Protocol Chair. There will be only one version of the protocol, and each participating institution will use that document. The Protocol Chair is responsible for assuring that all participating institutions are using the correct version of the protocol.  
- The Protocol Chair is responsible for the overall conduct of the study at all participating institutions and for monitoring its progress. All reporting requirements to CTEP are the responsibility of the Protocol Chair.  
- The Protocol Chair is responsible for the timely review of Adverse Events (AE) to assure safety of the patients.  
- The Protocol Chair will be responsible for the review of and timely submission of data for study analysis.
untitled h1
responsibilities of the coordinating center

- Each participating institution will have an appropriate assurance on file with the Office for Human Research Protection (OHRP), NIH. The Coordinating Center is responsible for assuring that each participating institution has an OHRP assurance and must maintain copies of IRB approvals from each participating site.  
- Prior to the activation of the protocol at each participating institution, an OHRP form 310
(documentation of IRB approval) must be submitted to the CTEP PIO.  
- The Coordinating Center is responsible for central patient registration. The Coordinating Center is responsible for assuring that IRB approval has been obtained at each participating site prior to the first patient registration from that site.  
- The Coordinating Center is responsible for the preparation of all submitted data for review by the Protocol Chair.  
- The Coordinating Center will maintain documentation of AE reports. There are two options for AE reporting: (1) participating institutions may report directly to CTEP with a copy to the Coordinating Center, or (2) participating institutions report to the Coordinating Center who in turn report to CTEP. The Coordinating Center will submit AE reports to the Protocol Chair for timely review.  
- Audits may be accomplished in one of two ways: (1) source documents and research records for selected patients are brought from participating sites to the Coordinating Center for audit, or (2) selected patient records may be audited on-site at participating sites. If the NCI chooses to have an audit at the Coordinating Center, then the Coordinating Center is responsible for having all source documents, research records, all IRB approval documents, NCI Drug Accountability Record forms, patient registration lists, response assessments scans, x-rays, etc. available for the audit.  
117 CTEP Study \#: 9243  
| 17.6 APPENDIX F: CCR PROBLEM REPORT FORM CC Protocol #: Protocol Title:  Report version: (select one) ____Initial Report  ____Revised Report ____Follow-up  Site Principal Investigator: Date of problem: Location of problem: (e.g., patient's home, doctor's office) Who identified the problem? (provide role (not name of person): nurse, investigator, monitor, etc…) Brief Description of Subject (if  applicable) (Do NOT include personal  identifiers) Sex: ___ Male ___ Female Age:  ___ Not applicable (more than subject is involved) Diagnosis under study:  Name the problem: (select all that apply)  [ ] Adverse drug reaction  [ ] Abnormal lab value  [ ] Death  [ ] Cardiac Arrest/ code  [ ] Anaphylaxis  [ ] Sepsis/Infection  [ ] Blood product reaction   |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|  
118 CTEP Study \#: 9243
[ ] Unanticipated surgery/procedure [ ] Change in status (e.g. increased level of care required) [ ] Allergy (non-medication)
[ ] Fall
[ ] Injury/Accident (not fall) [ ] Specimen collection issue [ ] Informed consent issue [ ] Ineligible for enrollment [ ] Breach of PII [ ] Tests/procedures not performed on schedule [ ] Other, brief 1-2 word description: _________________________
Detailed Description of the problem: (*Include any relevant treatment, outcomes or pertinent history*): *Is this problem unexpected? *(see the definition of unexpected in the protocol))* __YES __NO **Please explain:**
*Is this problem related or possibly related to participation in the research? __YES __NO Please explain:
*Does the problem suggest the **research places subjects or others at a greater risk of harm than was previously**
known or recognized? __YES __NO **Please explain:**
Is this problem? (*select all that apply*)
[ ] An Unanticipated Problem* that is: [ ] Serious [ ] Not Serious [ ] A Protocol Deviation that is: [ ] Serious [ ] Not Serious [ ] Non-compliance *Note if the 3 criteria starred above are answered, "YES", then this event is also a UP.  
119 CTEP Study \#: 9243 Is the problem also *(select one)* [ ] AE [ ] Non-AE
Have similar problems occurred on this protocol at your site? __YES __NO
If "Yes", how many? ____ Please describe:
Describe what steps you have already taken as a result of this problem:
In addition to the NHLBI **IRB, this problem is also being reported to:** (*select all that apply*)
[ ] Local IRB [ ] Study Sponsor [ ] Manufacturer : ____________________ [ ] Institutional Biosafety Committee [ ] Data Safety Monitoring Board [ ] Other: ____________________________________ [ ] None of the above, not applicable INVESTIGATOR'S SIGNATURE: DATE: