Protocol Screening Form for Research Nursing and Study Team
Instructions: This form is used to help ensure that all information requirements needed for the activation of a new Protocol are contained in the new document being submitted. The considerations below are subject to research pharmacy and research nursing review prior to protocol approval.
ü If required content is not included in the protocol, please contact the Sponsor and request the required information along with any other outstanding issues which need to be addressed by the study team prior to OHRS submission.
ü In cases where the protocol document is not owned by a DF/HCC Principal Investigator, an alert page may be necessary (where noted below). If the sponsor has agreed to standard institutional practices which differ from, or are missing from the protocol, the information must be placed on an Alert Page.
ü For any section below where a required item is pending discussion/resolution with the sponsor, please utilize the comment sections below stating that the Sponsor has been notified, a response has been requested, and is forthcoming. Please also identify which section of the protocol is requiring further action or follow-up.
Protocol Title:/
Overall PI Name and Institution: /
Research Nurse Review and Sign Off /
Name: /
Signature: / Date: /
Key: ü = All Required ¨ = At Least One Required Ø = Important to Note *Please explain all pending items in the Comment Section. /
# / Consideration / Explanation / Required Items / Verified /
1. / The protocol must contain the following information for all study agents being given on a protocol: / This information is needed to build Beacon orders appropriately. . / ü a. Dose (e.g., drug “X” given at 50 mg)
ü b. Drug strength being supplied (e.g., 25mg and 100mg)
ü c. Route of administration (e.g., intravenous infusion vs. oral)
ü d. Order of administration, if multiple study agents (e.g., drug ‘X” infused 30 min after completion of drug “Y”)
ü e. Frequency (e.g., given days 1,3,5 of each cycle)
ü f. Cycle length (e.g., cycle 28 days long)
g. Rate of infusion for IV medications (e.g., given over 60 min) / Yes
Pending*
N/A
Comments:
2. / If FDA-approved drugs are part of the study regimen, the protocol document must include either: / This information is needed to ensure proper administration of approved drugs. / Instructions on how the drug is administered OR
A statement that drug may be administered per institutional standards OR
A statement that drug may be administered according to the package insert OR
A statement that drug may be administered per MD discretion / Yes
Pending*
N/A
Comments:
3. / For oral agents, the following information must be included in the protocol: / Detailed information allows us to properly instruct participants on dosing procedures and avoid violations. / ü Written dosing instructions to be given to participants should be provided based on institutional practice.
ü a. Instructions on whether or not the study medication can be crushed, chewed, or dissolved in water.
ü b. Instructions for refrigerated oral agents: how long can oral agents be stored in ambient temperature?
ü c. Whether a participant can be re-dosed after vomited doses, and instructions including the timing of the re-dose.
ü d. Whether there is a window of time after the scheduled dosing time during which a forgotten/missed dose may still be taken without having to actually miss the dose.
ü e. If there are fasting requirements, include the number of hours required before and/or after each dose.
ü f. If fasting is required, is water permitted during any fasting periods?
ü g. If participant is required to eat, include the number of hours before and/or after each dose.
ü h. Prohibited foods should be stated (e.g., grapefruit, starfruit) if applicable.
ü i. Instructions for rounding doses as it relates to tablets or capsule size availability, as applicable.
ü j. If a drug diary is being used, it must be included with the submission.
Ø If available, information regarding the quantity and packaging of the drug to be dispensed to individual participants should be provided. / Yes
Pending* N/A
3a. / For oral agents when an in-clinic dose is needed / Information is necessary to convey to the Epic/Beacon build team for Beacon order production. / ü Requires in-clinic dose?
Ø Identify cycle and day when oral drug is to be given in clinic
Ø Worksheet completed and emailed to .
Ø Confirm any need for observation times; particularly for oral agents / Yes
N/A
Comments:
4. / The protocol must define any allowable time windows for the following, as applicable: / Reasonable treatment windows help us avoid violations and the need for deviations. This information may determine on what clinical floor(s) the trial will be conducted. / ü a. Dosing time points (e.g., drug must be taken 6 hrs apart, +/- 15 min)
ü b. Protocol specific procedures (e.g., ECGs, PKs, vital signs, +/- 10 mins)
ü c. Infusion time (e.g., drug must be infused over 90 min, +/- 10 min)
ü d. If a 10-hour or 12-hour post-dose PK is required, can protocol required labs be drawn the day before? / Yes
Pending* N/A
Comments:
5. / The protocol must include instructions on dose calculations for all study agents, as applicable: / EPIC/Beacon standard practice is to recalculate weight based dosing only when there is a change of 5% in patient weight.
Beacon (DFCI and MGH) can only be built to calculate BSA using the Dubois formula. / Ø If the protocol does not specify, or requires doses to be calculated differently, please ask the sponsor whether local standards may be used. Please post the sponsor response on the alert page.
Ø Beacon can only be built to calculate BSA using the Dubois formula. If the protocol does not specify, or requires the use of a different formula, please inform the sponsor of local standard for BSA calculation. An alert page will then be required to clarify that the Dubois formula will be used.
Ø If the protocol specifies differential dosing for male vs. female participants, confirm that this is reflected in the Beacon orders. / Yes
Pending* N/A
Comments:
6. / The protocol must define all hematologic and non-hematologic toxicity criteria for dose modification(s): / Detailed information allows us to properly manage toxicities and helps us avoid violations. / ü a. When to hold drug (e.g., at what grade of toxicity) and state the maximum length of time the drug can be held.
ü b. When to restart each study drug after a hold (e.g., to what grade must the toxicity resolve before drug(s) can be given again and/or when must the drug(s) be held permanently).
ü c. When to reduce the dose and what are the criteria that need to be met to reduce to the next lowest dose level. (It’s recommended that this be formatted as a table with dose level cohorts.)
ü d. Criteria for removing participant from trial or permanently holding a drug (e.g., maximum number of dose reductions or dose holds).
ü e. Guidance on whether holds affect dosing or assessment schedules (e.g., when a drug is held, particularly in the middle of a cycle, does the cycle day count change, stay the same, or does the cycle restart?)
ü f. The use of standard dose modification terminology: “dose modifications per institutional standard or package insert”, if applicable. / Yes
Pending* N/A
Comments:
7. / For phase I trials, the protocol must clearly define the following: / Allows for opening of new cohorts quickly / At least one of the following:
Dose level cohorts (e.g., a dose escalation table that states all actual doses being given at each dose level cohort)
If dose level cohorts are not defined in advance, information is contained in the protocol explaining how the Sponsor will decide new doses prior to the time that each cohort opens for enrollment. To open each cohort, an alert page, documentation from the sponsor, and an Administrative Update Form will need to be submitted to OHRS.
All of the below:
ü a. Criteria to treat a Dose Limiting Toxicity (DLT) (e.g., is the DLT handled the same as the criteria for dose modification toxicity criteria?)
ü b. The DLT determination period (e.g., a toxicity is a DLT during Cycle 1 only).
ü c. Criteria to treat after the DLT period (e.g., a toxicity is a DLT during Cycle 1, after Cycle 1 should be managed as a toxicity).
ü d. For trials using oral agents, define amount/percentage of doses necessary to be taken to be considered evaluable for DLT (excluding holds for toxicity/ recovery). / Yes
Pending* N/A
Comments:
8. / The protocol schema diagram must not include information on drug doses: / Dosing information on schema may lead to dosing errors and violations / Ø For DF/HCC PI-initiated trials, doses cannot be provided in the schema.
Ø For externally-sponsored trials, please verify that the doses are expressed in exactly the same way as in the protocol text. / Yes
Pending* N/A
Comments:
9. / The protocol must define Day 1 procedures as related to treatment, including: / In order not to delay the start of a cycle / ü a. If labs are obtained on C1, D1, do the results have to re-meet eligibility criteria? Please note that this question is NOT asking if labs must be drawn on C1, D1. The goal is to determine whether or not a participant will be able to be treated on C1, D1.
ü b. Do the results of D1 labs of any cycle need to be reviewed before treatment?
ü c. If there are clinical safety labs that require prolonged time for results (i.e. TSH or GGT), discuss with the sponsor if treatment can be administered prior to the results of these tests. The clarification must be placed on the ALERT PAGE.
ü d. AT MGH, it is preferable to use serum pregnancy testing rather than urine testing. Confirmation by sponsor should be placed on Alert Page. / Yes
Pending* N/A
Comments:
10. / Assessment schedules and required data tables must be consistent with the protocol text: / Inconsistency within the protocol may lead to errors and violations / Ø Verify that all tables are consistent with the written information within the protocol sections. Please discuss any discrepancies with the sponsor and an alert page may be necessary for any needed clarifications. / Yes
Pending* N/A
Comments:
11. / Pharmacy Manuals / Inconsistency between the pharmacy manual and the protocol may lead to dosing errors and violations / Pharmacy drug manual (if being used in the study)
Verify that the drug administration section in the pharmacy manual is consistent with the drug administration instructions in the protocol. Any discrepancies must be discussed with the sponsor and an alert page may be necessary for any required clarifications.
Ø In some cases, the pharmacy drug manual may be incorporated into other manuals, such as the lab manual.
Ø NOTE: The “Investigator Brochure” is NOT posted in OncPro and any information not in the protocol that is referenced as being found in the IB will not be available after activation. Therefore, the information needs to be added as appendices so that the Infusion Nurses treating the Participants have access to the information. / Yes
Pending* N/A
Comments:
12. / The study team must confirm whether the study will utilize central labs and/or central EKGs: / Needed for budgeting and clinical care / Ø For central labs, please verify what labs need to be repeated for clinical care vs. research-specific labs that do not need to be repeated (e.g., CBC and/or chemistry panels will need to be drawn for local results and drawn to be sent to central lab).
Ø Equipment supplied by a sponsor (e.g., EKG machines or Holter Monitors) that will be used on a patient, or by a patient, MUST BE inspected and approved by Biomedical Engineering according to institutional policy.
Ø With regard to Sponsor provided EKG machines and Holter Monitors:
Does the protocol state whether or not the results are to be reviewed by the treating Institution in real time and if reviewed, are there instructions, in the protocol, as to any actions to be taken if irregularities are observed? / Yes
Pending* N/A
Comments:
13. / Injectable study drugs: If the Sponsor is supplying the syringes for injectable study drugs, please confirm that safety needles are being supplied. / Safety needles must be used to administer all injectable drugs in the clinic. / Ø If needles are being supplied by the Sponsor, please check the type of needle(s) being supplied to ensure that only safety needles are supplied. If non-safety needles are being supplied, the Sponsor must switch to a safety needle or allow DF/HCC institutions to use their own safety needles for administration of injectable study drug(s) in clinic. / Yes
Pending* N/A
Comments:
14. / Please confirm whether the study requires the use of equipment that could result in logistical issues at their institution (e.g., syringe pump or overfills). / Some institutions will not use syringe pump or overfills. / Ø Contact research pharmacy prior to submission so that the issue can be discussed with the sponsor.