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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

Siteman Cancer Center

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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