Protocol and Consent Development Checklist
All protocols should be dated, have numbered pages, and include a table of contents; subsequent versions (revisions or amendments) should also be dated and include a version number.
DISCLAIMER: Each protocol is unique. Thus, no protocol format (or checklist) will be applicable to all protocols. This checklist applies principally to therapeutic (drug) trials. Additionally, it contains many elements that may not be applicable to all therapeutic trials. It is provided to aid investigators in protocol development.
TITLE PAGE:
Date of document
Protocol number (e.g. 96-0001)
Title of protocol
Does title accurately represent or include all aspects of the protoc***
Principal Investigator - name, name of institution, address and phone number
List of other participating facilities
Name of coordinating center if a multi-site trial
Co-investigators or co-chairs for each modality (e.g. radiation, surgery, laboratory)
Statistician
1.0 Introduction - Background and Rationale
Is sufficient background given to understand the reason(s) for conducting this study and for estimating the expected risks and benefits of this study?
Is the rationale clearly stated for correlations between tumor characteristics and outcome measurements?
For therapeutic protocols, provide response data, toxicity and complications and supportive care measures from similar studies
Is information provided to support all ancillary studies?
Are references given for all statements for which they are needed?
For Phase I studies, is the dose-limiting toxicity, pharmacokinetics/dynamics, either in animals or humans, adequately defin***
2.0 Objectives - Primary endpoints of study, listed and numbered individually.
Are objectives stated clearly?
Is study design appropriate to answer questions posed by these objectives?
Revised October 1, 2002 1
Adapted from the NCI Investigator’s Handbook
3.0 Selection of Patients - Eligibility Criteria
Should include:
Disease type/site
Extent or stage of disease
Whether disease must be measurable or evaluable and a definition of each
What pathology is required - e.g. if protocol is for advanced disease, is recent biopsy proof of recurrent or metastatic disease required or only the initial biopsy of primary?
What pathological materials, if any, are to be sent and where?
Prior therapies permitted and/or not allowed
Performance Status
Required physiologic status laboratory parameters
Age range specified (no upper age limit is permitted by the NCI unless justified scientifically)
Statement regarding ineligibility if female subject is pregnant or lactating
Statement advising women of childbearing potential and sexually active males to use effective contraception while on study
Statement that patient must have signed informed consent of a HSC approved protocol prior to registration on study.
4.0 Patient Registration
Are procedures for registration clear - what data are needed to register, who to call, etc.?
If a multicenter trial, are patients registered through a central office?
Does required information include description of randomization process, patient characteristics, and stratification factors?
5.1 Treatment Plan
5.2 Administration
Administration - are instructions for mixture or preparation and administration of all drugs given in clear detail such that they can be followed by all research personnel?
Are the following clear?
Route of administration (e.g. IM, SQ, IT, IV bolus, IV infusion, oral); time (over minutes or hours; 3X per day at mealtime, etc.); days (e.g. days 1-5, 8 and 10).
Hydration, urine alkalization, electrolytes, I & O
Treatment intervals (how often, e.g. q 3 weeks, daily for 28 days, etc).
Total duration of treatment (for a maximum of cycles or until progression, or other specified time e.g. IV infusion over 2 hours on days 1 and 5 q 3 weeks for a maximum of 4 cycles).
Radiation therapy dose and schedule
Integration of multimodality therapy (surgery, radiation therapy, chemotherapy)
5.3 Schema
If a schema is given, is it complete and accurate when compared to this section? At a minimum, all treatment studies must have a schema.
5.4 Dose Modifications
Are criteria for grading toxicities for dose modifications specified and included with the protocol, and are they described using NCI Common Toxicity Criteria?
Is it clear when and how toxicity is to be assessed - whether by nadir counts or current values and at what points during therapy?
Are instructions included for dose modification of each study drug?
Are instructions included for each modality (chemotherapy, radiation therapy)?
Are all reasonable measures included to monitor expected adverse events?
Are instructions given for reporting Adverse Drug Reactions?
5.5 Duration of Therapy
Are conditions given for taking patient off study (e.g., if grade 4 , patient should go off study; or, if treatment is held x times for toxicity, patient must go off study).
5.6 Supportive Care
Are guidelines given for supportive care?
Should special instruction sheets be included if patients are to give themselves injections?
Are patient diaries included (if applicable) to record when drug is taken and any side effects?
6.0 Response Assessment
Is “adequate course,” defined, i.e., how much therapy must a patient receive to be evaluable for response?
Are criteria provided for assessing response for the following categories, depending on what is permitted in the protocol?
bidimensionally measurable disease
unidimensional disease
nonmeasurable evaluable disease
leukemia/lymphoma
Categories of response defined - What constitutes a complete response, partial response, minor response, stable disease and progression (NCI categories for Quarterly Reports)?
7.0 Study Parameters - Tabular format preferred
All required laboratory tests, imaging studies and measurements, ancillary laboratory tests, etc. should be included in chart format so that the times at which they are required are clear.
Are all laboratory tests, imaging studies, etc. required in eligibility section listed here? Please list any that should be added.
Do any tests seem unnecessary - e.g., SGPT is not included in standard SMAs.
Is it clear from the charts how often test are to be done? Are intervals reasonable?
Time limit for pre-study laboratory tests and imaging studies (how many days/weeks before beginning on study?)
8.0 Drug Formulation and Procurement - Is the following information given for each study drug?
Other names, if any, for the drug
Classification - type of agent
Mode of action
Storage and stability
Dosing - Specific to this study
Preparation - diluent to be used, etc.
Route of administration - study specific
Incompatibilities
Availability - source of drug (NCI, pharmaceutical company, commercially available)
Are agent ordering procedures clear if the agent (e.g., a drug) is provided?
Side effects - for each drug
Nursing implications
Adequate description of Reported Adverse Events and Potential Risks given? Is an Investigator’s Brochure included if applicable?
9.0 Statistical Considerations Is the statistical section adequate with regard to the following?
Method of randomization and stratification
Sample size determinations
Error levels (alpha and beta) in phase III studies
Differences to be detected and size of the confidence interval
Estimated accrual rate and/or study duration, with supporting documentation
Early stopping procedures
Primary endpoint for interim and final anaylses
Clear specification of primary and secondary (e.g., subset) hypotheses
Maximum number of patients
Statistical analysis
10.0 Recordkeeping
Does protocol specify data to be collected, at what intervals, and to whom sent?
Are intervals reasonable?
Are data collection forms included?
Are reporting guidelines and timing of data submission forms clear?
11.0 References
Do references agree with numbers in the body of the protocol?
12.0 Special Considerations
Are personnel identified?
Are instructions re: methods of preparation and shipment (types of tubes, spun, frozen, on wet/dry ice or at room temperature, sent by overnight mail or batched, etc.) adequ***
For ancillary laboratory studies -
Are instructions re: methods of preparation and shipment (types of tubes, spun, frozen, on wet/dry ice or at room temperature, sent by overnight mail or batched, etc.) adequa***
For patient self-administered drug:
Are patient diaries or calendars for drug administration and recording side effects included?
12.0 Informed Consent
The following elements must be present in the informed consent document:
Does the consent clearly state that the study involves research.
State which drug(s), treatment(s), or delivery technique(s) is/are experimental?
Clarify the study purpose(s) is layman’s terms (HSC suggests 6th Grade reading level)
State the patient’s expected duration of participation in study (e.g., the patient will be treated until there is evidence that therapy is no longer effective).
Give a brief description of the procedure(s) to be performed to monitor the patient during study (e.g., X-rays, lab evaluations, etc.). An exhaustive list is not necessary.
Give a description of the experimental aspect(s) or new delivery techniques(s) of the study.
State in specific terms the route of administration of each drug (e.g., I.V., oral, continuous infusion, etc.)
State estimated time of delivery of each drug or time of procedure (e.g., 5 minutes, 30 minutes, 24 hours, etc.).
State which risks are attributed to specific drug(s) or procedure(s).
Clarify and describe expected benefit(s) to be derived from participation in this study.
In general terms, discuss alternative treatment(s) to participation in this study (e.g., conventional chemotherapy, irradiation, hormonal therapy, surgery, etc.).
State the extent to which confidentiality of records will be maintained.
State if compensation for study-related injury will be provided by the institution or other insurer.
Provide space in the form or list name(s) and number(s) of the contact person(s) (not involved in the research) for patients rights related questions.
Include SCC Registry statement in consents for all trials (available at the HSC website).
Additional Elements
The following elements may be appropriate for some studies:
State that unforeseeable or unexpected risk(s) may be involved.
State the circumstances under which the patient’s participation may be terminated by the investigator without the patient’s consent.
State that additional costs may be incurred by the patient’s participation in the study.
State the consequences of the patient’s decision to withdraw from the study.
State that significant new findings that relate to the patient’s treatment will be discussed with the patient.
State the approximate number of patients involved in the study.
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建立和建立與社區醫生的關系
向社區醫生提供有關Siteman醫師，多學科服務，臨床試驗和轉診流程的信息，以及癌癥中心提供的新技術和程序
確定社區醫師對繼續教育活動的興趣
促進Siteman醫生介紹適當的轉診醫師
通過與適當的斯特曼醫生和工作人員分享信息解決轉診和后續交流問題
斯特曼的醫師服務代表如下所列，致力于提供卓越的服務和建立系統和流程，重點關注患者和醫生的需求。他們歡迎詢問和反饋。要聯系代表，請使用下面提供的聯系信息。
聯系方式：
Barbara Buesse
醫師外展協調員
314-454-***
buesseb**[ta]**sis.wustl.edu
斯科特EisbrennerScott Eisbrenner
314-454-***
eisbrenners**[ta]**sis.wustl.edu
瑪麗米勒Mary Mueller
314-454-***
muellerm**[ta]**sis.wustl.edu
SLU聯盟成員，請聯系Chris Cox
314-747-***
coxc**[ta]**sis.wustl.edu
巴納德健康和癌癥信息中心
凱瑟琳•瓊斯
辦公室協調員
電話：314-362-***
郵箱：kdj3988**[ta]**org
patientliaison**[ta]**org
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