If you don’t include this information, the app review process may be delayed and your app may not pass review. To conclude, both expedited and full reviews play a crucial role in the clinical study process. Finally, it’s important to note that the review process, whether expedited or full, needs to be conducted in compliance with various regulatory affairs. Xpedite facilitates collaboration, by making it easy for developers to share, profile and analyze results with other developers. The list of supported metrics can be displayed with xpedite metrics command. Given a topdown node, xpedite automatically resolves and enables the required performance counters, and generates statistics for topdown nodes in addition to performance counters. The rest of the nodes, can be used directly with pmc parameter in profileInfo.For instance, TopdownNode('Root') will provide a breakup of the following immediate children. Finalize all images and text before submitting for review. A link to user support with up-to-date contact information and a link to your privacy policy is required for all apps. Submit items for review only when they’re complete and ready to be published. Watch “Tips for preventing common review issues” We’ve highlighted some of the most common issues to help you better prepare before submitting for review. Auto generating profileInfo module The build process will produce a static library, libxpedite.a, which can be linked into a C++ executable(if you want to use xpedite in a position independent executable, the build produces a different static library to use, libxpedite-pie.a). Due to this, sampling profilers typically end up profiling the least interesting part of the code, while ignoring the critical path. Profiling such low-latency systems becomes a real challenge, with off the shelf sampling profilers like linux perf or Intel vtune. A non-sampling profiler, purpose built to measure and optimise, performance of ultra-low-latency / real time systems. Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified. If your submission didn’t pass review, details are provided, including any specific App Review Guidelines that your submission didn’t follow. If you need to provide partnership documentation or authorization, attach the files in the Attachment section in App Store Connect and provide any descriptions or links in the Review Notes field. Certain types of apps must be submitted by the legal entity that provides the services rather than an individual developer. Before creating your app, take a look at the apps in your category on the App Store and consider how you can provide an even better user experience. This visualisation is a good starting point for getting an overview of application's latency profile.Collection of data from voice, video, digital, or image recordings made for research purposes.If your app appears to promise certain features and functionalities, it needs to deliver.Xpedite provides a handy command xpedite generate, that can locating probes in an instrumented process, to generate the profileInfo module.Recording a new profile with the updated profileInfo, will benchmark statistics for current run with baseline.As shown below, the histogram for the new run, includes latency distribution of the baseline, in addition to the current run.With the above instrumentation in place, each iteration of the loop in life(), will hit the following 4 probes in order.Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis). In reports with multiple benchmarks, the reference benchmark can be change by using the drop down at the top of the table. For instance, Running xpedite record as described in the previous section, with an additional parameter -b /tmp/baseline creates a new benchmark at /tmp/baseline Let's consider how to create a new benchmark, for a run of the above described application. Benchmarking is useful to compare performance statistics of different runs/builds side by side, to answers questions like the ones stated below. Regardless of the type of review, the study must comply with Good Manufacturing Practice (GMP) and analytical method validation requirements.We’ve highlighted some of the most common issues to help you better prepare before submitting for review.Watch “Do more with less data”As you plan and build, use these guidelines and resources to help the review process go as smoothly as possible.Xpedite grew in the world of automated low latency trading systems, where latency directly translates to profitability.Let's look at, how profile info and instrumentation work together to build transactions, in the above program.Instead of listing all transactions, let's just list outliers (transactions, that took longer than expected)In the above program, the AppInfo is placed at filesystem path "/tmp/xpedite-appinfo.txt".The second argument is an optional boolean parameter, to make the application wait, till a profiler attaches to the process. The commands described above are useful, to query/visualize profile data at trasaction level granularity. A transaction stores data (timestamps and h/w counters) from a collection of probes, that got hit, during program execution to achieve the functionality. The shell also supports commands to filter, query and dynamically generate other visualisations to analyze profile data. Alternatively, moving mouse over a counter name, shows the value of that counter at different sections of code. Moving mouse over a probe name, shows values of all the counters for that section of code. First start the target app (described above), using taskset -c 5 ./life to pin the main thread to core 5. For instance, running xpedite list in my IVY Bridge server box, lists 355 pmc events as shown below. If your submission is incomplete, review times may be delayed or your submission may not pass. On average, 90% of submissions are reviewed in less than 24 hours. If your app requires specific settings, user account information, or special instructions, include these details in the App Review Information section of App Store Connect. Apple App review usually takes 24 hours to complete. Although the criteria for each review type differ, both aim to ensure that the study is conducted in the most ethical and safe manner possible. If you followed all the steps, listed in the previous sections, by now you would have built a program called "life".Starting the program from a command line will, print messages similar to ones shown below. Finally, To build this simple program, add the two snippets above to a file called Life.C and run We instrument the code by inserting probes (XPEDITE_TXN_SCOPE, XPEDITE_PROBE), so that sections of code, are encapsulated by a pair of probes. Building To learn more, view Preventing Copycat and Impersonation Rejections and guideline 4.1. When requesting permission to access user or usage data, you should clearly and completely describe how your app will use the data. Specific documentation is required for certain scenarios and types of apps. Enter all of the details needed for review in the App Review Information section of App Store Connect. Items that are still in progress and contain placeholder content are not ready to be distributed and cannot be approved.Clicking on the ipynb link, opens a interactive shell, with a summary of the profile.In the chart below, it can be seen that, the outlier occurs at the beginning of the profile session.If your app requires specific settings, user account information, or special instructions, include these details in the App Review Information section of App Store Connect.In reports with multiple benchmarks, the reference benchmark can be change by using the drop down at the top of the table.However, if your app is still in review and the launch of your event is quickly approaching, you can request to have your app review expedited.To get consistent results, threads under profile, must be pinned to one of the cpu cores, to prevent cpu migrations. You can also check the review status of your submission in the Apps section of App Store Connect or on the App Store Connect app for iPhone and iPad. Get in-depth details on the technical, content, and design criteria that we use for review, and learn about other key guidelines. Learn about the guidelines your submission needs to follow and information you’ll provide for review. Soon, the Apple Review team should start reviewing your app. For those interested in a Regulatory affairs career in pharma, understanding the review process is crucial. To accept, simply reply to the offer message in App Store Connect and indicate you would like the current submission to be approved. Make sure your request includes the event, date of the event, and your app’s association with the event. Learn about corresponding with App Review You can correspond with App Review to resolve the issues before resubmitting the build. Txns() command generates transactions in a table, similar to the one shown above.However doing mouse over on a table cell, reveals a popup showing performance counter data, for that section of code. The stats() command generates total and probe level statistics, for all the transactions in the profile. In the above program, the AppInfo is placed at filesystem path "/tmp/xpedite-appinfo.txt".The second argument is an optional boolean parameter, to make the application wait, till a profiler attaches to the process. All links in your app must be functional. Thanks to this approach, if you have a critical update for your app, you can use this path to meet important deadlines. Apple gives developers the ability to use the fast track for App Review. Below the summary, the report will include a histogram for latency distribution, plotting time in x-axis and transaction count in y-axis.But there are situations like app crashes or meeting marketing campaign deadlines when you need to publish the changes ASAP.This can be achieved by following the Analytical method validation ICH guidelines.On average, 90% of submissions are reviewed in less than 24 hours.To learn more, view Preventing Copycat and Impersonation Rejections and guideline 4.1.Profiling starts with careful instrumentation of application code with probes.Let's consider how to instrument a simple C++ program.Let's consider how to create a new benchmark, for a run of the above described application.With the above code stored in the file profileInfo.py, let's build a profile by running the application, followed by attaching xpedite to it. The transactions can be used to generate statistics and visualisations for total end to end latency, and latency between each pair of probes. For instance, running xpedite command txns() will print a table with 100 transactions (as shown below). This visualisation is a good starting point for getting an overview of application's latency profile. To attach the profiler to the running process, invoke xpedite record -p profileInfo.py -H 1 from console.If everything works, the profiler after collecting profile data from the target process, will start an instance of jupyter. With the above code stored in the file profileInfo.py, let's build a profile by running the application, followed by attaching xpedite to it. Below the summary, the report will include a histogram for latency distribution, plotting time in x-axis and transaction count in y-axis. Clicking on the ipynb link, opens a interactive shell, with a summary of the profile. Browsing the url, opens a page with a list of xpedite reports (files with .ipynb extension).Your page may contain, just one report as shown below. By understanding these review processes and the criteria involved, researchers can ensure their studies comply with all necessary guidelines and regulations.Thanks to this approach, if you have a critical update for your app, you can use this path to meet important deadlines.Additionally, full reviews require careful documentation and adherence to guidelines, which can be facilitated through SOP training pharma and a comprehensive Pharma SOP checklist.You can also check the review status of your submission in the Apps section of App Store Connect or on the App Store Connect app for iPhone and iPad.Looking at the first row, we can see the below stats for the first transactionThe max, 95%, 99% and standard deviation in the above table are skewed by inclusion of the huge outlier.Let's see how to generate statistics, for a subset of transactions. Guidelines What we really need is an intrusive profiler, which can target and collect samples only during execution of desired critical path(s). Sampling profilers, as the name implies, will sample timestamps and performance counters from the cpu, based on some counter firing frequency. Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. Regardless of the type of review, the study must comply with Good Manufacturing Practice (GMP) and analytical method validation requirements. Full review criteria often include studies that involve physical risk to the participants, sensitive topics or vulnerable populations. On the other hand, a full review is required for studies that present more than minimal risk to the participants or involve vulnerable populations. Both of these reviews have their own unique set of criteria that must be met in order to proceed. The comments in the genreated file are also useful, as a documenation for various profileInfo parameters. Alternatively, moving mouse over a counter name, shows the value of that counter at different sections of code.Your app should be engaging and useful, and make the most of the features unique to iOS.You can request an Expedited Review by going to developer.apple.com and singing in to your developer account.Your suggestions will be taken into consideration by App Review.This command will be quite handy to filter transactions of interest, based on arbitrary criteria.Similarly, Analytical Method Validation is crucial in confirming that the analytical procedure employed for a specific test is suitable for its intended use.A non-sampling profiler, purpose built to measure and optimise, performance of ultra-low-latency / real time systems. Submitting for review Similarly, Analytical Method Validation is crucial in confirming that the analytical procedure employed for a specific test is suitable for its intended use. For more information, you can refer to GMP validation and ensure your study is congruent with these guidelines. For production systems, it is a good practice to run xpedite in a host different from the production host, to avoid any potential interference. Track your app & your competitors Before any new drug, medical device or treatment can be introduced to the market, it must undergo a rigorous review process to ensure it is safe and effective. Xpedite supports profiling applications running in any remote host, as long as a tcp connectivity is permitted.Remote profiling can be enabled, by setting the appropriate remote host name in appHost parameter of the profileInfo module. On the other hand, a xpedite tar file can be reopened using xpedite shell unzip command, with file name as parameter. You can view your past and current submissions to App Review in App Store Connect. You can also visit the Apple Developer Forums or request code-level support. View guideline 3 and guideline 5.1.1. If your app doesn’t offer much functionality or content, or only applies to a small niche market, it may not be approved. If your app appears to promise certain features and functionalities, it needs to deliver. A profile can be compared with one or more benchmarks, by providing a list of paths in benchmarkPaths parameter of profileInfo.Let's add /tmp/baseline to the list of benchmarkPaths. Let's filter and plot, only transactions that took less than 10 micro seconds. In the above chart, the first transaction hides details of all other transactions. In plots with outliers, It's typical for worst transaction, to dominate the scale of the y-axis, hiding details of normal transactions. The AppInfo file forms the link between Xpedite profiler and a running instance of an application.Given a valid AppInfo file, the profiler can, attach and profile the process that created the file. Profiling starts with careful instrumentation of application code with probes.Let's consider how to instrument a simple C++ program. This program is a hello world example of - How to profile a c++ program with xpedite. Meet with App Review over Webex to discuss the App Review Guidelines and explore best practices for a smooth review process. All apps submitted to App Store Connect that access user data are required to include a purpose string. For applications instrumented with hundreds of probes, it can become a chore to hand code all the probes in the profileInfo module. The jupyter notebook (along with transaction data and visualisations) can be bundled into one tar file (.tar.xp) using xpedite shell zip command. Once the app is running, Run xpedite record to attach the profiler and generate report with performance counter data. The statistics for end to end transaction latency is show at the last row.The rest of rows provide statistics for different sections of code, between pair of probes, for all probes in the transaction. Let's look at, how profile info and instrumentation work together to build transactions, in the above program. But there are situations like app crashes or meeting marketing campaign deadlines when you need to publish the changes ASAP. Having a Validation master plan pharma can also be extremely beneficial in streamlining the process. This can be achieved by following the Analytical method validation ICH guidelines. The jupyter notebook (along with transaction data and visualisations) can be bundled into one tar file (.tar.xp) using xpedite shell zip command.Up to 8 pmc events can be programmed in modern Intel processors (Sandy Bridge and later), when hyper threading is disabled.The topdown hierarchy for any micro architecture can be rendered to console with xpedite topdown command.Nodes that need more than 8 general purpose counters are not supported and highlighted in Red.If you’re facing extenuating circumstances, such as fixing a critical bug or releasing your app to coincide with an event, you can request an expedited review by completing this form.Whenever these issues happen, it is important that you react in a timely manner to minimise the impact that the incident has for your users and to also prevent your app’s rating from plummeting.Before any new drug, medical device or treatment can be introduced to the market, it must undergo a rigorous review process to ensure it is safe and effective. This command will be quite handy to filter transactions of interest, based on arbitrary criteria. From the table, Let's see, how one can infer latency stats for a transaction. Let's see an example of a minimalistic profileInfo, that can be used to profile the above program. In the chart below, it can be seen that, the outlier occurs at the beginning of the profile session. Plot() is useful to plot, latencies of all transactions in chronological order, with transaction id in x-axis and time (us) in y-axis. Instead of listing all transactions, let's just list outliers (transactions, that took longer than expected) In the above chart, the first transaction hides details of all other transactions.Full review criteria often include studies that involve physical risk to the participants, sensitive topics or vulnerable populations.In this article, I will show you how you can request an expedited review from Apple’s developer portal.You can view your past and current submissions to App Review in App Store Connect.Let's see an example of a minimalistic profileInfo, that can be used to profile the above program.To build xpedite, you will need cmake 3.4 or later, GNU gcc 5.2 or later, and a version 2.5 or later Linux kernel.The rest of the nodes, can be used directly with pmc parameter in profileInfo.For instance, TopdownNode('Root') will provide a breakup of the following immediate children. It is also important to note that failing to comply with this guidance and submitting excessive expedited review requests might result in Apple ignoring future requests. In this article, I will show you how you can request an expedited review from Apple’s developer portal. Submitting several apps that are essentially the same ties up the App Review process and risks your apps not passing review. Stability studies also play a crucial role in the review process. Additionally, full reviews require careful documentation and adherence to guidelines, which can be facilitated through SOP training pharma and a comprehensive Pharma SOP checklist. These studies need to be reviewed by a full board of experts, and the process can take several months to complete. Improve your review experience — and the experience of your future users — by thoughtfully combining your apps into one. If your app’s code references one or more APIs that access sensitive user data, the app’s Info.plist file should contain a $! As you plan and build, use these guidelines and resources to help the review process go as smoothly as possible. We review all apps, app updates, app bundles, in-app purchases, and in-app events submitted to App Store Connect to help provide a safe and trusted experience for users and the opportunity for developers to succeed. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.) You can request an Expedited Review by going to developer.apple.com and singing in to your developer account. What most iOS developers don’t know though is that there is a way you can tell the App Review team that there is an urgent new version of your app in review and get it reviewed faster using Expedited Reviews. Even if you have found the root cause of the issue and have a build ready to be released very quickly, your app still needs to go through the review process before you can ship it to all your users. Apps that actively try to copy other apps won’t pass review. The commands described above are useful, to query/visualize profile data at trasaction level granularity.To accept, simply reply to the offer message in App Store Connect and indicate you would like the current submission to be approved.Even if you have found the root cause of the issue and have a build ready to be released very quickly, your app still needs to go through the review process before you can ship it to all your users.Websites served in an iOS app, web content that is not formatted for iOS, and limited web interactions do not make a quality app.Benchmarking is useful to compare performance statistics of different runs/builds side by side, to answers questions like the ones stated below.For instance, running xpedite list in my IVY Bridge server box, lists 355 pmc events as shown below.Access the App Review section on the app’s page in App Store Connect.It is also important to note that failing to comply with this guidance and submitting excessive expedited review requests might result in Apple ignoring future requests. The explicit path statements may not be necessary, depending on where/how xpedite have been installed on your system. The demo source also serves as working example of xpedite instrumentation and profiling. To build xpedite, you will need cmake 3.4 or later, GNU gcc 5.2 or later, and a version 2.5 or later Linux kernel. Xpedite grew in the world of automated low latency trading systems, where latency directly translates to profitability. Your app must perform as advertised and should not give users the impression the app is something it is not. When working on your app, focus on creating interesting, unique experiences that aren’t already available. Websites served in an iOS app, web content that is not formatted for iOS, and limited web interactions do not make a quality app. Plot() is a also useful to plot a single transaction, when supplied with transaction id as arugment. Looking at the first row, we can see the below stats for the first transaction With the above instrumentation in place, each iteration of the loop in life(), will hit the following 4 probes in order. Transaction is any functionality in the program, that is a meaningful target for profiling and optimisations. Before you go any further, Let's take a moment to get familiar with a core xpedite concept. If you’re facing extenuating circumstances, such as fixing a critical bug or releasing your app to coincide with an event, you can request an expedited review by completing this form. However, if your app is still in review and the launch of your event is quickly approaching, you can request to have your app review expedited. When submitting an expedited review to fix a critical bug, include the steps to reproduce the bug on the current version of your app. Running plot(4), plots a hierarchical break up of latency statistics for fourth transaction, as shown below. In addition to total time, plots are generated for each pair of probes in the transaction.The drop down menu at the top can be used to pick plots for different sections of code. Plots like these are useful, to spot patterns or trends in transaction latency over a period of time.These patterns can provide interesting insights on application behaviour, bottlenecks, impact of system level events like periodic interrupts etc. The topdown hierarchy for any micro architecture can be rendered to console with xpedite topdown command.Nodes that need more than 8 general purpose counters are not supported and highlighted in Red. The list of pmc events and cpu cores (where the threads are pinned), can be configured in profileInfo as shown below. To get consistent results, threads under profile, must be pinned to one of the cpu cores, to prevent cpu migrations. Up to 8 pmc events can be programmed in modern Intel processors (Sandy Bridge and later), when hyper threading is disabled. Xpedite can collect any of the core and offcore hardware performance counters, for bottleneck or topdown analysis.The list of counters supported, depends on processor's micro architecture and can be listed by running xpedite list Profiler Initialization Collection of data from voice, video, digital, or image recordings made for research purposes. Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis). Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. App Review submissions Stat() command generates a statistics table for each of the chosen counter, in addition to default timings statistics.The tabs at the top of the table can be used to select stats for different counters. Let's consider, how to configure xpedite to program and collect data from hardware performance counters. The stat() command goes one step further and generates side by side comparisons for each section of code (each table cell).The stats for the current run are highlighted with reference to a benchmark. Benchmarks are created by serializing and storing profile data in some file system path, for future comparisons.Benchmarks are also useful, in keeping a chronicle of all optimisations, implemented over a period of time. Let's now explore, how to generate statistics, for a group of transactions. Having a Validation master plan pharma can also be extremely beneficial in streamlining the process.The statistics for end to end transaction latency is show at the last row.The rest of rows provide statistics for different sections of code, between pair of probes, for all probes in the transaction.For production systems, it is a good practice to run xpedite in a host different from the production host, to avoid any potential interference.From the table, Let's see, how one can infer latency stats for a transaction.If you don’t include this information, the app review process may be delayed and your app may not pass review.For instance, running xpedite command txns() will print a table with 100 transactions (as shown below).For instance, a profileInfo for the program (described above), can be generated using command xpedite generate -a /tmp/xpedite-appinfo.txt. The expedited review process is typically faster than a full review and is used for studies that present minimal risk to the participants. For instance, a profileInfo for the program (described above), can be generated using command xpedite generate -a /tmp/xpedite-appinfo.txt. Xpedite provides a handy command xpedite generate, that can locating probes in an instrumented process, to generate the profileInfo module. Your app should be engaging and useful, and make the most of the features unique to iOS. Including an example can help users understand why your app is requesting access to their personal information. Watch “Do more with less data” Items that are still in progress and contain placeholder content are not ready to be distributed and cannot be approved. View guideline 2.1 and guideline 5.1. Once you have done so, click the ‘Send’ button to forward the request to the App Review team. Whenever these issues happen, it is important that you react in a timely manner to minimise the impact that the incident has for your users and to also prevent your app’s rating from plummeting. There are certain times when a version of your app has a bug or crash in production that majorly impacts most or all of users. You can contact us to ask for support with an unresolved app rejection or removal. Your suggestions will be taken into consideration by App Review. Expedited review is more than just expedient review. If you believe that an app presents a trust or safety concern, or is in violation of the App Review Guidelines, you can share details with us to investigate. Help improve the App Review Guidelines or identify a need for clarity in our policies by suggesting guideline changes. Access the App Review section on the app’s page in App Store Connect. Experience the WCG difference starting with a free ethical review consultation. Director, Expedited Review IRB Operations This review is done by a single IRB Board member (reviewer) instead of a convened board.