5.6. Data management (data collection, source and storage)

Describe the steps that will be taken to secure the data (e.g., training, authorization of access, password protection, encryption, physical controls, certificates of confidentiality, and separation of identifiers and data) during storage, use, and transmission. Also include if others will have access to the data collected and where data will be stored (e.g. REDCap, Google Sheets, or both). 

5.7. Follow-up and end-of study (if applicable)

5.8. Statistical Method

5.8.1. Sample size calculation and justification

Justification can include a statistical sample size calculation (with methods and results) or a description of the number of eligible participants seen in your practice during the study period.

5.8.2. Statistical Analysis Plan

Please consult with a biostatistician to add the plan here. To request support use the following link: https://redcap.link/HMH.Biostats 

Primary Analysis

Secondary Analysis (if applicable)

Exploratory Analysis (if applicable)

Interim Analysis (if applicable)

Sample language: Quantitative study: The surveys will be scored according to instructions provided by the authors of those instruments. Cronbach’s alpha will be determined for each instrument. The demographic data will be analyzed using standard descriptive statistics. Descriptive statistics will be conducted to determine the frequencies and distributions of the data. Based on the data distribution, the relationships and differences among the study variables will be determined with parametric or nonparametric correlational statistics, with a significance level of α = 0.05. 

6 – Trial Administration

The sections below (or some of the sections) might not be necessary depending on the study type and/or study design. Please delete if not applicable. 

6.1. Ethical Considerations – Institutional Review Board (IRB) Review

Sample language: The study will be conducted according to the International Conference on Harmonization (ICH), Good Clinical Practice (GCP), the Declaration of Helsinki, Institutional Review Boards (IRB) and in accordance with the U.S. Code of Federal Regulations on Protection of Human Rights (21 CFR 50).

6.2. Institutional Review Board (IRB) Review (list the IRB of record)

Sample language: The final study (ICF, HIPAA form as applicable) and data collection tools will be approved by the Institutional Review Board (IRB) at HMH. Approval will be received in writing before any study activities are initiated. 

Any changes to the study design will be formally documented in modifications and will be approved by the IRB prior to implementation.

6.3. Privacy and Confidentiality

The investigator should explain how participant confidentiality will be preserved, how data will be kept confidential and used for professional purposes, whether charts will be coded, kept in locked files, etc.

All protocols require one of the following:

1. A HIPAA Authorization (as part of the informed consent form)

2. A Request to Waive Authorization for the Use of PHI for Research Purposes

3. A Data Use agreement (for use with limited data sets)

Sample language (for coded data): Patient charts, collected data, and analyses of the data will adhere to HIPAA & institutional patient confidentiality requirements.  A unique identifier (study ID number) will be assigned to each patient.  The study ID number will be included in the data collection tools and analysis software while the list with direct identifiers and ID numbers will be stored separately in a HMH password protected computer and/or locked office. 

If results of the study are published, individual names or other identifying information will not be used.

6.4. Informed consent 

Indicate whether you will you be obtaining consent, and if so describe:

• Where will the consent process take place?

• Any waiting period available between informing the prospective subject and obtaining the consent.

• Any process to ensure ongoing consent.

• Process to document consent

• Steps that will be taken to minimize the possibility of coercion or undue influence (especially if participants are employees or students/residents).

Steps that will be taken to ensure the subject’s understanding. 

Use of Legally Authorized Representatives

• Use of legal authorized representatives (LARs) for inclusion of decisionally impaired subjects who lack capacity to consent for themselves is governed by New Jersey statute. If LARs will or could be used, indicate in this section. In addition, HMH IRB requires the completion of the LAR form found in the ‘Templates’ section of the eResearch Library. Please complete the LAR form and upload as part of the application (under ‘Other Attachments’ on the “Local Site Documents” page). 

To request a full waiver of consent, describe:

• How the research involves no more than minimal risk to the subjects; 

• Why the research could not practicably be carried out without the requested waiver;

• If the research involves using identifiable private information or identifiable biospecimens, why the research could not practicably be carried out without using such information or biospecimens in an identifiable format;

• Why the waiver will not adversely affect the rights and welfare of the subjects; and

• Whenever appropriate, if the subjects or legally authorized representatives will be provided with additional pertinent information after participation

If using Protected Health Information (PHI) for research purposes, to request a waiver of HIPAA authorization, describe: 

• How the use or disclosure of PHI involves no more than a minimal risk to the privacy of individuals;

• Why the research could not practicably be conducted without the waiver

• Why the research could not practicably be conducted without access to and use of the PHI

To request a waiver of documentation of consent (waiver of signed consent, such as using an Information Sheet as a consent form in which signatures are not collected), describe:

• How the only record linking the subject and the research would be the informed consent form and the principal risk would be potential harm resulting from a breach of confidentiality; OR

• How the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context; OR 

• How the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.

If using Protected Health Information (PHI) for research purposes, to request an alteration of HIPAA authorization (by removing the required element of signed authorization), describe: 

• How the use or disclosure of PHI involves no more than a minimal risk to the privacy of individuals;

• Why the research could not practicably be conducted without the alteration (i.e. why obtaining signed authorization is not practicable); 

• Why the research could not practicably be conducted without access to and use of the PHI

Sample language for use of Information Sheet for Participation in Research: At the beginning of the survey or interview or focus group, the Investigators or the participant will read or have participants read the Information Sheet for Participation in Research and ask if the participant has any questions. The information sheet includes elements of informed consent: 1) an explanation of the purpose of the study; 2) an explanation that there will be no direct benefits and minimal risks to participation; 3) an assurance of confidentiality; and 4) an assurance of the participant’s right to choose not to participate or to terminate participation at any time during the interview. Participants will be advised that participation is voluntary and whether they participate or not will not affect their employment in any way. Consent will be considered implied upon completion of the survey or participation in the interview or focus groups.

6.5. Data Management and Sharing Plan

(Sections  with * are required only for federally funded studies)

6.5.1. Data Sources 

Who will provide the data needed, e.g. DTS/Data Analytics/Department records, how will you obtain your list of subjects, e.g. ICD codes being used, specific diagnosis, specific patient population, where are charts located, who will review the charts, etc. If data is going to be requested from DTS, please note that a request will need to be placed directly to the DTS team through MySupport. 

If you are prospectively collecting your own data, please clarify what will be your data source if any. 

6.5.2 Data type 

Summarize the types of scientific data expected to be generated in the project, including if data will be digital or not. 

E.g. Clinical Data, genetic data, genomic data 

6.5.3 Estimated amount 

Summarize the estimated amount of scientific data expected to be generated in the project.

Sample language: Genomic data will be generated for all 100 patients participating in this study. 

6.5.4 Data storage 

While HMH does not mandate the use of REDCap for all research projects, use of this research tool is encouraged. If another data repository is to be used, identify it and please clarify measures to protect confidentiality. 

Clarify if data will be stored internally as identifiable data (identifiers stored within the dataset); code (identifiers are collected but are stored separately from the main dataset); de-identified (identifiers are accessed but are NOT collected for the study) OR anonymous (identifiers are never accessed for the study). Also explain where data will be stored. 

Sample language: Data will be coded and a unique study number will be assigned to each study record. The key linking identifiers to the unique study number will be kept separately from the main dataset that will be used for data analysis. All data will be stored within the HMH Google Suite and will only be accessible by the IRB approved study team.  

6.5.5 Scientific data that will be shared and means of transmission 

Summarize what will be shared outside HMH. Type N/A if no data will be shared. 

“Scientific data” is defined as data commonly accepted in the scientific community of sufficient quality to validate and replicate research findings, regardless of whether the data are used to support scholarly publications. 

Includes: any data needed to validate and replicate research findings. 

Sample language: De-identified data will be shared with our xx collaborator. Data will be shared over secured email.   

6.5.6 Scientific data to be published

Summarize your publication plan. 

Sample language:  Results from this study will be submitted for publication to a peer review journal such as xx. 

6.5.7 Record Retention 

Describe how long records will be retained after the completion of the study

Sample language: Records will be retained in accordance with regulatory and organizational requirements, but for no less than six (6) years following the completion of the study.  Disposal of records will be performed according to regulations  in a manner such that identifiers cannot be linked back to the study data (if applicable). [See HRPP SOPs section 19 and adjust as applicable]

6.5.8 Data Quality Assurance 

Describe the quality control and assurance for the conduct of the study to ensure that Good Clinical Practice is followed. Any steps that will be implemented as part of the study to ensure standardization of the collection of accurate, consistent, complete and reliable data, such as training sessions, monitoring of investigator sites, instruction manuals, use of central laboratory, or reading center should be included.

6.5.9 Data Preservation, Access, and Associated Timelines*

Provide the name of the repository(ies) where scientific data and metadata arising from the project will be archived. Also include if digital data contain any private, privileged, or otherwise confidential information will be shared and what will be redacted before public release. 

Type N/A if no data will be archived.

Sample language: This study will be registered on ClinicalTrials.gov in compliance with federal regulations and institutional policy. Aggregate results from this study will be posted on ClinicalTrials.gov within 365 days from the study’s Primary Completion date. No individual participant data (IPD) will be made available or be shared on ClinicalTrials.gov. 

6.5.10 Related Tools, Software and/or Code*

State whether specialized tools, software, and/or code are needed to access or manipulate shared scientific data, and if so, provide the name(s) of the needed tool(s) and software and specify how they can be accessed.

Type N/A if not applicable. 

6.5.11 Standards*

State what common data standards will be applied to the scientific data and associated metadata to enable interoperability of datasets and resources and provide the name(s) of the data standards that will be applied.  Describe how these data standards will be applied to the scientific data generated by the research proposed in this project. If applicable, indicate that no consensus standards exist.

Type N/A if not applicable.

6.5.12 Access, Distribution, or Reuse Considerations*

Describe and justify any applicable factors or data use limitations affecting subsequent access, distribution, or reuse of scientific data related to informed consent, privacy and confidentiality protections, and any other considerations that may limit the extent of data sharing.

Type N/A if not applicable.

6.6. Compensation for Research-Related Injury (if applicable)

If the research involves more than Minimal Risk to subjects, describe the available compensation in the event of research related injury (please make sure it matches the language in the relevant legal agreements and the consent form).

6.7. Economic Burden to Subjects (if applicable)

Describe any costs that subjects may be responsible for because of participation in the research.

6.8. Credentials, Training

Any training should be addressed. Any additional investigators should be mentioned specifically. Please make sure study related, as well as institutional required credentials/training is mentioned here. 

6.9. Financing and Insurance (if applicable)

Describe the funding of the study and insurance coverage if applicable. 

6.10 Investigator(s)’ financial and other relevant personal interests (only specify if you have interests that are relevant to the conduct of this study)

7- Resources Available

7.1. Describe the resources available to conduct the research: 

For example, as appropriate:

• Justify the feasibility of recruiting the required number of suitable subjects within the agreed recruitment period. For example, how many potential subjects do you have access to? What percentage of those potential subjects do you need to recruit?

• Describe the time that you will devote to conducting and completing the research.

• Describe your facilities.

• Describe the availability of medical or psychological resources that subjects might need as a result of an anticipated consequence of the human research.

• Describe your process to ensure that all persons assisting with the research are adequately informed/trained about the protocol, the research procedures, and their duties and functions.

8 – Multi-Site Research  (you may delete this section if not applicable)

8.1. Study-Wide Number of Subjects

If this is a multicenter study, indicate the total number of subjects to be enrolled across all sites.

8.2. Study-Wide Recruitment Methods

• If this is a multicenter study and subjects will be recruited by methods not under the control of the local site (e.g., call centers, national advertisements) describe those methods.  

• Describe when, where, and how potential subjects will be recruited.

• Describe the methods that will be used to identify potential subjects.

• Describe materials that will be used to recruit subjects. (Attach copies of these documents with the application. For advertisements, attach the final copy of printed advertisements. When advertisements are taped for broadcast, attach the final audio/video tape. You may submit the wording of the advertisement prior to taping to preclude re-taping because of inappropriate wording, provided the IRB reviews the final audio/video tape.)

• If this is a multi-site study where you are the lead investigator, describe the processes to ensure communication among sites. 

• All required approvals (initial, continuing review and modifications) have been obtained at each site (including approval by the site’s IRB of record).

• All modifications have been communicated to sites and approved (including approval by the site’s IRB of record) before the modification is implemented.

• All engaged participating sites will safeguard data, including secure transmission of data, as required by local information security policies. As well as all the necessary legal agreements (e.g.  Data Use/Collaboration Agreements)

• All local site investigators conduct the study in accordance with applicable federal regulations and local laws.

• All non-compliance with the study protocol or applicable requirements will be reported in accordance with local policy.

8.3. Describe the method for communicating to engaged participating sites 

• Problems (inclusive of reportable events).

• Interim analysis results.

• The closure of a study.

8.4. If this is a multicenter study where you are a participating site/investigator, describe the local procedures for maintenance of confidentiality. 

• Where and how data or specimens will be stored locally?

• How long will the data or specimens be stored locally?

• Who will have access to the data or specimens locally?

• Who is responsible for receipt or transmission of the data or specimens locally?

• How data and specimens will be transported locally?

References (make sure you provide the references cited in section 2)

APA preferred for citation of references or as otherwise required.

Appendix/Appendices

The Appendices should contain items such as surveys, permission to use survey letter/email, demographic data form, interview guide, and data collection sheet.

Appendix 1 – Data collected 

Appendix 1- Data Collection Tool (to be deleted if not applicable)

If data collection takes place as part of the study, a complete list with all data points to be collected needs to be included here or be uploaded as a separate attachment during IRB submission.

If applicable, the data collection sheet can also be included here. 

Example Data collection Form:

Example table (to be modified to reflect the fields that will be collected) 

Common sections include: Demographics – Comorbidities – Outcomes / Procedures – Medication (each type or class of medication needs to be listed separately, if important the class should be listed in a separate column)